Kornimate/medical-research-clean huggingface dataset:
ivi-guided versus angiography-guided pci in patients with diabetes mellitus

Conditions: Diabetes

Summary: intravascular ultrasound (ivus) serves as a beneficial instrument during percutaneous coronary intervention (pci) procedures, affording insight into lesion characteristics and stent implantation. the ultimate trial recently evidenced that ivus-guided drug-eluting stent (des) implantation notably ameliorated clinical outcomes in all-comers, especially in patients who underwent an optimal procedure defined by ivus, as opposed to angiography guidance, resonating with findings from the ivus-xpl study, october trial, and renovate complex pci trial, further confirmed by more recent ivus-acs trial. optical coherence tomography (oct) has a resolution 10 times higher than that of ivus and can provide valuable information at each step of pci. regrettably, a dearth of prospective, randomized, multicenter trials exists that scrutinize the benefits of ivi-guided as opposed to angiography-guided pci in patients suffering from diabetes mellitus. however, several trials have presented subgroup analyses reporting the reduction of clinical events by ivus but not oct guidance in patients with diabetes mellitus, which served as the foundation for the design of this trial.

the current study hypothesizes that ivi-guided pci will be superior with respect to target vessel failure (tvf), including cardiac death, target-vessel myocardial infarction (tvmi), or clinically-driven tvr when compared with angiography-guided pci in patients with diabetes mellitus.

Eligibility criteria:
inclusion criteria: 1. age between 18 \~ 80 years old, 2. confirmed diabetes mellitus 3. indications for undergoing percutaneous coronary intervention using a drug-eluting stent (invasive or quantitative fractional flow reserve (qfr or ffr) \<0.80) 4. silent angina, stable angina, unstable angina, or non-st-elevation myocardial infarction exclusion criteria: 1. cardiogenic shock 2. previous coronary artery bypass graft (cabg) 3. left ventricular ejection fraction \< 30% 4. requiring oral anticoagulation medications 5. any planned surgery within 12 months 6. severe chronic kidney disease defined as an estimated glomerular filtration rate (egfr) \< 20 ml/min/1.73m2 7. platelet count \< 100,000 mm3 8. contraindication to study medications or metal 9. women of childbearing potential 10. life expectancy \< 1 year 11. any condition likely to interfere with study processes including medication compliance or follow-up visits (e.g. dementia, alcohol abuse, severe frailty, long distance to travel for follow-up visits, etc.)
functional connectivity in relation to proprioception and sensorimotor recovery in stroke patients (feasibility study)

Conditions: Stroke

Summary: the purpose now is to: 1. identify brain connections related to proprioception to have a better understanding of differences between people with stroke and healthy persons 2. evaluate how these brain connections will change in people with stroke when they are engaged in 6-week cognitive multisensory rehabilitation.


Eligibility criteria:
inclusion criteria: inclusion criteria for healthy subjects are: * medically stable; * 18 - 99 years of age; * able to hear the instructions given during the study inclusion criteria for stroke patients are: * at least 6 months post-stroke; * medically stable; * 18 - 99 years of age; * subcortical or cortical infarct confirmed with mri; * mini-mental state exam \> 24/30 (folstein et al., 1975); * able to hear the instructions given during the study; * able to comprehend the instructions given during the study; * able to commit time to participate in a 6-12-weeks rehabilitation program exclusion criteria: * having ever experienced a stroke or another brain injury or illness related to the brain that has lasting effects or effects experienced at the moment of recruitment; * severe sensory impairments such that different movements of the finger, hand or wrist are not reliably felt; * contractures in tested arm that hinder persons from keeping the outstretched arm in a relaxed position; * interfering comorbidities (e.g. fracture, cancer, peripheral neuropathy); * exhibit contra-indications to enter the magnetic field of the 3t (pacemakers, metal parts in the body etc); * pregnant or nursing mother; * adults lacking capacity to consent
vojta therapy in early stroke rehabilitation

Conditions: Vojta Therapy; Reflex Locomotion

Summary: stroke is the major cause for permanent disability in adults. it is still unclear, which physiotherapeutic approaches are most effective. the bobath-concept is one of the most widely used approaches in stroke rehabilitation within the western world, although several studies have failed to demonstrate superiority and showed partially even inferiority compared to other physiotherapy approaches. the vojta therapy is based on a completely different approach - the reflex locomotion. however to date no study has been performed for stroke. we designed a randomized clinical trial (rct) to compare vojta and conventional physiotherapy in patients with acute ischemic (ais) or hemorrhagic stroke (ich). this rct will be the first trial to investigate improvement of postural control due to vojta therapy in early rehabilitation of stroke patients, which is a very new approach in stroke-rehabilitation.


Eligibility criteria:
inclusion criteria: * adult patients (\> 18 years) * ct or mri proven acute ischemic (ais) or hemorrhagic stroke (ich) within 72h after onset of symptoms * severe hemiparesis (medical research council scale for muscle strength ≤2) * premorbid modified rankin scale (mrs) ≤3 * maximal national institute of health stroke scale score (nihss) 25 * voluntary written consent by the patient exclusion criteria: * severe cognitive impairment due to aphasia or dementia, prohibiting that physiotherapeutic challenges can be understood. * participation on another clinical trial * pregnancy

Keywords: vojta therapy reflex locomotion stroke rehabilitation stroke physiotherapy
study of metabolic effects of pregnancy in women with cystic fibrosis

Conditions: Cystic Fibrosis

Summary: objectives: i. compare the clinical status of pregnant vs non-pregnant women with cystic fibrosis. ii. determine glucose tolerance during each trimester of pregnancy in these women. iii. evaluate peripheral insulin sensitivity in these women. iv. evaluate whole body protein turnover and hepatic glucose production in these women. v. determine resting energy expenditure in these women.

protocol outline: patients undergo a glucose tolerance test over 3 hours and a potassium body scan on day 1. patients undergo an indirect calorimetry over 20 minutes on day 2. patients receive stable-labeled leucine and stable-labeled glucose iv over 3 hours followed by insulin and glucose iv over 4-4.5 hours on day 2 using the hyperinsulinemic euglycemic clamp technique. blood and breath samples are collected to measure glucose tolerance, peripheral insulin sensitivity, and whole body protein turnover. hepatic glucose production is measured by mass spectrophotometry. patients maintain a 3-day food journal before pregnancy, during each trimester, and after pregnancy. patients undergo each study during the final 2 weeks of each trimester of pregnancy and then at 6 months post-partum.

Eligibility criteria:
protocol entry criteria: --disease characteristics-- * diagnosis of cystic fibrosis (cf) and pregnant or age, weight, and body mass index matched non-pregnant cf woman or pregnant non-cf woman * no infection with burkholderia cepacia * fev1 at least 60% --prior/concurrent therapy-- * at least 3 weeks since prior corticosteroids --patient characteristics-- * hepatic: no more than one transaminase level greater than 10% above normal other: pregnant non-cf controls: * no cigarette smokers * no history of gestational diabetes mellitus * no type 1 or 2 diabetes * no other chronic illness

Keywords: cardiovascular and respiratory diseases cystic fibrosis genetic diseases and dysmorphic syndromes rare disease
effects of s. boulardii and amoxicillin/clavulanate on gut microbiota

Conditions: Healthy Volunteers

Summary: the purpose of this study is to compare and contrast the effects of the probiotic saccharomyces boulardii, the antibiotic amoxicillin/clavulanate and the combination on the gut microbiota of healthy volunteers.


Eligibility criteria:
inclusion criteria: * age 18 to 65 years (male or female) * good general health * able to comply with study requirements and to provide informed consent * for women of childbearing potential oa negative urine pregnancy test immediately prior to starting the study treatment oagreement to comply with approved methods of contraception during the period of active study treatment (not required during follow-up) exclusion criteria: * history of organ transplantation * known chronic or recurrent systemic disorder associated with immunocompromise * a history of allergy or hypersensitivity to saccharomyces boulardii, brewer's or baker's yeast, amoxicillin, penicillins, or cephalosporins * history of severe allergic reaction (requiring hospital admission and/or the administration of parenteral medication or associated with dyspnoea, wheezing, hypotension, loss of consciousness). * oral or systemic antibacterial therapy during the 3 months prior to study enrollment * new prescription medications during the 4 weeks prior to study enrollment * prescription, otc medications or supplements that are known to alter gut function or microflora (i.e. acid antisecretory drugs, probiotics) during the 4 weeks prior to study enrollment * active gastrointestinal disease * patients with a central venous catheter * patients taking antifungals or laxatives within 14 days of enrolment * patients enrolled in other clinical trials within the past 60 days * prior gastrointestinal surgery (apart from appendectomy or cholecystectomy) * history of chronic constipation with passage of fewer than 3 bowel movements per week on average * any condition or personal circumstance that, in the opinion of the investigator, renders the subject unlikely or unable to comply with the full study protocol.

Keywords: human gut microbiota gut microbiota gut microbiome probiotic antibiotic antibiotic-associated diarrhea intestinal bacterial overgrowth
association of centre of excellence self-administered questionnaire (cesam) score and frailty levels

Conditions: Chronic Disease; Frailty; Disability Physical

Summary: this study evaluates the association of the self-administered questionnaire (cesam) score and its stratification of frailty in four levels with incident adverse health events in older community dwellers and to compare this association with three validated frailty indexes which are the cardiovascular health study frailty index, study of osteoporotic fracture index and rockwood frailty index.

older adults' health and functional status is heterogeneous because of the various cumulative effects of chronic diseases and physiologic decline, contributing to a vicious cycle of increased frailty. thanks to advances in medicine and hygiene, a growing number of older adults spend more years with a greater range of disorders causing disability but not mortality. health systems thus need to face this new challenge. quantification of frailty and its association with the occurrence of adverse health events is crucial to understand how efficiently health systems may respond to this situation. this study aims to examine the association of the cesam score and its stratification of frailty in four levels with incident adverse health events in older community dwellers and to compare this association with a) five validated frailty indexes which are the cardiovascular health study frailty index, study of osteoporotic fracture index, rockwood frailty index, 6-item brief geriatric assessment (bga) and "program of research on the integration of services for the maintenance of autonomy" (prisma-7) and b) two new frailty indexes developed over the covid-19 pandemic which are "évaluation socio-gériatrique" (esoger) and "criblage et recommandations" (care).

Eligibility criteria:
inclusion criteria: -healthy community-dwellers from quebec, canada exclusion criteria: -community-dwellers from outside quebec, canada
ovarian screening study

Conditions: Ovarian Cancer

Summary: the objectives of this study are: * to identify women at increased risk for developing ovarian cancer * to detect ovarian cancers at an early stage * to investigate the role of tumor membrane fragments as tumor markers for early ovarian carcinoma

in the year 2001 approximately 23,400 women in the usa are expected to be diagnosed with ovarian carcinoma and 13,900 will die of the disease. this means that within the usa more women die annually from ovarian cancer than all other gynecologic malignancies combined. within the commonwealth of kentucky approximately 250 women per year develop ovarian carcinoma. survival for patients with ovarian cancer is directly related to the stage of disease at diagnosis. unfortunately, the majority of women present with advanced disease (stage iii and iv) and most of these patients will die of the disease. the aim of screening for ovarian cancer is to reduce the morbidity and mortality by detecting the disease at an early stage since ovarian cancer detected when disease is confined to the ovary (stage i) is associated with a dramatically improved 5-year survival. disease confined to the ovary may be cured in over 90% of patients, in some cases without the need for chemotherapy.

Eligibility criteria:
inclusion criteria: * asymptomatic women over the age of 45 with one or both ovaries. * women over the age of 25 with one or both ovaries and any of the following: * a personal history of breast, colon or endometrial cancer or breast cancer gene (brca) 1 or 2 positive * first-degree relative (mother, sister, daughter) with ovarian or breast cancer * two family members with either breast and/or ovarian cancer * mother, sister, daughter, grandparent with a positive brca1 or brca2 genetic test result. * past use of fertility drugs such as clomid or pergonal for more than a year. exclusion criteria: * women who are symptomatic of ovarian cancer

Keywords: ovarian cancer
left ventricular function assessment after acute myocardial infarction: comparison between bi-, three-dimensional and cardiac magnetic resonance

Conditions: Acute Myocardial Infarction

Summary: compare measurements of left ventricular volumes and lvef obtained by 2de, 3de, and cmr after a st elevation myocardial infarction (stemi) complicated by systolic left ventricular dysfunction

the assessment of left ventricular ejection fraction (lvef) is a critical step after a myocardial infarction because it determines the prognosis and the therapeutic management (indication of implantable cardioverter-defibrillators). three-dimensional echocardiography (3de) and cardiac magnetic resonance (cmr) are accurate and reproducible techniques to quantify left ventricular volumes and lvef. however, all the large randomized trials which evaluated the role of the implantable cardioverter-defibrillators (icd) on survival in primary prevention were based on lvef values obtained by older techniques like bi-dimensional echocardiography (2de), angiography or radionuclide scanning. from now, no study has compared the measurements of left ventricular volumes and lvef obtained by further current techniques after an acute myocardial infarction (ami) particularly after 1 month when icd could be indicated.

Eligibility criteria:
inclusion criteria: * all the patients presenting a first ischemic clinical episode for at least 30 minutes, associated with one known gap will be included in a forward-looking and consecutive way, of at least 0.1mv in at least two peripheral diversions of the same territory or of at least 0.2 mv in at least two precordial diversions of the same territory * an initial fevg (measured by echocardiography or ventricular angiography in the daytime of the admittance) exclusion criteria: * age \< 18 years * antecedents of idm * contraindications in the mri (claustrophobia, stimulating and defibrillators heart patient implantable, metal intraocular brightness, allergy in the gadolinium, the severe renal insufficiency with clearance in the creatinine ≤30 ml/min) * fibrillation little finger * pregnancy.

Keywords: the assessment of left ventricular ejection fraction (lvef)
vitamin d levels in children undergoing adenotonsillectomies and controls

Conditions: Tonsillitis

Summary: the investigators aim to evaluate the levels of serum vitamin d in children having their tonsils removed and appropriate controls. the investigators hypothesize that children undergoing tonsil removal will have lower vit d levels than accepted norms and when compared to controls. the investigators also hypothesize that vitamin d deficiency will correlate with indicators of inflammation such as c-reactive protein (crp) and tonsil size.


Eligibility criteria:
inclusion criteria: * children age 1-12 undergoing adenotonsillectomy (active) or elective surgery such as hernia repair (control) exclusion criteria: * children on systemic steroids or multivitamins containing vitamin d * control subjects with: a history of snoring, recurrent tonsillitis or score equal to or higher than 5 on the osa questionnaire.
phase ii clinical study of imatinib mesylate in patients with malignant gastrointestinal stromal tumors (extension study)

Conditions: Gastrointestinal Stromal Tumors

Summary: this is a extension study of csti571b1201 study


Eligibility criteria:
inclusion criteria: - patients who completed the csti571b1201 study exclusion criteria: - other protocol-defined inclusion / exclusion criteria may apply.

Keywords: gist imatinib sti571 gastrointestinal stromal tumors
allogenic ucmscs as adjuvant therapy for severe covid-19 patients

Conditions: Covid 19

Summary: this study is conducted to assess the efficacy and safety of stem cells as adjunctive treatment for severe covid-19 patients. here, we want to study whether the administration of mesenchymal stem cells are safe and able to relieve some of the covid-19 symptoms

this is a randomized controlled trial. double-blind, multi-center clinical study conducted at three different hospitals, on 21 patients who received intervention and 21 patients who received control treatment. the purpose of this study is to evaluate the efficacy and safety of intravenous administration of normoxic allogeneic umbilical cord-derived mesenchymal stem cell (ucmsc) in the treatment group, compared to the control group who are only given standard covid-19 treatments and normal saline infusion

Eligibility criteria:
inclusion criteria: * man or woman age 18-75 years * sars-cov2 positive as confirmed by sars-cov2 rt-pcr test * diagnosed with pnumonia as confirmed by chect radiography and history of fever, coug with one of the following symptoms: rr \> 30x per minute, sao2 93%, fao2/fio2 300 mmhg * voluntarily joined the clinical trial and has signed the informed consent form exclusion criteria: * pregnant and lactating woman * patient who are diagnosed or have history of tumor and cancer * patient whose mother or sister are diagnosed with breast or ovarian cancer * level of sgpt/alt is ≥ 5 times upper limit from normal value * level of egfr is \< 30 ml/min * reluctant to sign informed consent and unwilling to take the required tests * require invasive ventilation * shock * organ failure * currently involve in other clinical trial, or join another clinical trial in the last 3 months

Keywords: covid19 mesenchymal stem cells (mcss) adjuvant therapy indonesia
a study to investigate the safety and efficacy of ripasudil (k-321) eye drops after cataract surgery

Conditions: Corneal Edema After Cataract Surgery

Summary: the purpose of this study is to assess the safety and efficacy of k-321 in subjects after cataract surgery


Eligibility criteria:
inclusion criteria: * is at least 18 years old at the screening visit (visit 1). * is planning to undergo cataract surgery in the study eye and has had cataract surgery at visit 2. * can understand the written informed consent, provides signed written informed consent, and agrees to comply with protocol requirements before any study-specific assessment is performed. * meet all other inclusion criteria outlined in clinical study protocol. exclusion criteria: * is a female subject of childbearing potential and any of the following is true: 1. is pregnant or lactating/breastfeeding, or 2. has experienced menarche and is not surgically sterile, not post-menopausal (no menses for the previous 12 months), or not willing to practice an effective method of birth control during the study period as determined by the investigator (eg, oral contraceptives, double barrier methods, hormonal injectable or implanted contraceptives, tubal ligation, or partner with vasectomy). 3. has a positive urine pregnancy test result at visit 2 before cataract surgery. * had intraocular surgery (non-laser surgery) in the study eye within 6 months of visit 1. * had intraocular laser surgery in the study eye within 3 months of visit 1. * meet any other exclusion criteria outlined in clinical study protocol
the disorder of circadian clock gene and early cognitive dysfunction after general anesthesia

Conditions: Postoperative Delirium; General Anesthesia; Exosomes; Clock Gene; Circadian Rhythm Disorders

Summary: postoperative cognitive dysfunction (pocd) is a common postoperative complication in patients aged 65 and over, which refers to cognitive function changes such as memory decline and attention deficit after anesthesia and surgery. in severe cases, personality changes and social behavior decline may also occur, resulting in irreversible cognitive impairment.previous studies have suggested that cognitive dysfunction after general anesthesia is linked to a genetic disorder of the body clock.exosomes are cellular forms of cellular microvesicles containing complex rna and proteins.exosomes can mediate the expression of genes in the late transcriptional period of the clock system, and directly or indirectly participate in the negative regulation of rhythm expression of minute control genes, playing an important role in the intercellular circadian rhythm information output pathway.rhythm disorders in the core biological clock system of urinary exosomes and the clock control genes related to kidney can early indicate circadian rhythm changes in the core biological clock system.the sorting and detection of urinary exosome clock information materials in patients has the advantages of easy access, continuous monitoring, early diagnosis and less damage, making urinary exosome a biomarker for the diagnosis and monitoring of circadian rhythm of a good kidney biological clock system.


Eligibility criteria:
inclusion criteria: * patients whose age ≥ 18 years old and \<90 years of preoperative sleep disorder; * primary cancer patients who had not received any radiotherapy or chemotherapy before surgery; * surgeries expected to be performed under general anesthesia after ≧3 hours exclusion criteria: * a history of schizophrenia, epilepsy, parkinson's disease, or myasthenia gravis; * inability to communicate due to coma, severe dementia, language impairment or serious illness; * critically ill (preoperative asa (american society of anesthesiologists)\>iii), childe-pugh c or severe renal insufficiency (preoperative dialysis); * neurosurgery.

Keywords: postoperative delirium general anesthesia exosomes clock gene circadian rhythm disorders