Kornimate/medical-research-clean huggingface dataset:
children and adolescents with marfan syndrome: 10,000 healthy steps and beyond

Conditions: Marfan Syndrome

Summary: marfan patients are at risk of sudden death due to weakening of the wall of the large blood vessel leading from the heart (aorta). the wall of the aorta weakens and dilates which can rupture, leading to death, and sometimes during intense exercise. there is some evidence in marfan patients that a stiffer aorta increases risk for rupture. for some time, clinical care has focused on what type of exercise these patients should avoid due to risk for aortic dissection. little clinical emphasis has been placed on encouraging patients to engage in routine and safe exercise such as walking. informed by this evidence, the investigators propose to collaboratively investigate whether regular exercise improves aortic health in adolescent marfan patients.

marfan syndrome is an inherited disorder of the connective tissue, which provides material and support for the skeleton, muscles, and blood vessels. marfan patients are at risk of sudden death due to weakening of the wall of the large blood vessel leading from the heart (aorta). the wall of the aorta weakens and dilates which can rupture, leading to death, and sometimes during intense exercise. typically, the weakening process starts when elastin fibers in the aorta become fragmented. there is some evidence in marfan patients that a stiffer aorta increases risk for rupture. for some time, clinical care has focused on what type of exercise these patients should avoid due to risk for aortic dissection. little clinical emphasis has been placed on encouraging patients to engage in routine and safe exercise such as walking. these young patients also frequently choose sedentary lifestyles, most likely due to limitations imposed by parents as well as adolescents' own perceptions of what is safe for them and their physical capabilities. another complicating factor is that these patients often experience difficulty coping with their diagnosis. informed by this evidence, the investigators propose to collaboratively investigate whether regular exercise improves aortic health and coping skills in adolescent marfan patients.

Eligibility criteria:
inclusion criteria: 1. 10-19 years of age, 2. mfs by revised ghent criteria, 3. cardiac clearance to exercise by the primary cardiologist. exclusion criteria: 1. ventricular dysfunction, 2. prior history of aortic surgery.
comparison of the efficacy of transcutaneos nerve stimulations in women with idiopathic overactive bladder

Conditions: Urinary Bladder, Overactive

Summary: our study is the first prospective randomized controlled trial that compares the effectiveness of transcutaneous medial plantar nerve stimulation (t-mpns) and transcutaneous tibial nerve stimulation (ttns) added to bladder training (bt) in women with idiopathic overactive bladder (oab). i̇n this study, we aimed to assess the efficacy of t-mpns and ttns added to bt on quality of life (qol) and clinical parameters asssociated with idiopathic oab. in addition, preparation time for stimulation, treatment satisfaction and discomfort levels of the patients were evaluated. the main questions we aim to answer are: is t-mpns as effective as ttns in the treatment of idiopathic oab? for this purpose, we planned to compare transcutaneous applications of the tibial and plantar medial nerve in women with idiopathic oab. 60 women with oab will be randomized to 3 groups by using random number generator: bt program alone to group 1 (n=20), bt plus t-mpns to group 2 (n=20), bt plus ttns to group 3 (n=20) will be applied.

the main questions we aim to answer are: is t-mpns as effective as ttns in the treatment of idiopathic oab? for this purpose, we planned to compare transcutaneous applications of the tibial and plantar medial nerve in women with idiopathic oab. 60 women with oab will be randomized to 3 groups by using random number generator: bt program alone to group 1 (n=20), bt plus t-mpns to group 2 (n=20), bt plus ttns to group 3 (n=20) will be applied.

Eligibility criteria:
inclusion criteria: * women over the age of 18 with clinical diagnosis of idiopathic oab * not tolerated or unresponsive to antimuscarinics and discontinued at least 4 weeks * able to understand the procedures, advantages and possible side effects * willing and able to complate the voiding diary and qol questionnaire * the strength of pfm 3/5 and more exclusion criteria: * women with stress urinary incontinence * history of conservative therapy (bt, t-mpns and ttns/ptns) within 6 months * pregnancy or intention to become pregnant during the study * current vulvovaginitis or urinary tract infections or malignancy * anatomic or posttraumatic malformations/skin disorders of medial plantar/tibial nerve region on inner foot/ankle that cannot allow to apply the electrodes * more than stage 2 according to the pelvic organ prolapse quantification (pop-q) * cardiac pacemaker, implanted defibrillator * previous urogyneceological surgery within 3 months * neurogenic bladder, signs of neurologic abnormalities at objective examination; history of the peripheral or central neurologic pathology * ultrasonographic evidence of pvr volume more than 100 ml

Keywords: idiopatic overactive bladder transcutaneous medial plantar nerve stimulation transcutaneous tibial nerve stimulation
trial of avb-620 in women with primary, non-recurrent breast cancer undergoing surgery

Conditions: Breast Cancer

Summary: this is a phase 1, open-label, dose escalation study in women with primary, non-recurrent breast cancer undergoing surgery. avb-620 will be administered prior to surgery.

this study will examine the safety and tolerability of avb-620 administered as an iv infusion to women with primary, non-recurrent breast cancer undergoing surgery. the study will also characterize the pharmacokinetics of avb-620 in this subject population and determine the dose of avb-620 needed to generate a fluorescence signal in tumor and lymph node tissue to enable fluorescence recordings and image analysis with an imaging system. the study will also evaluate the effect of timing of avb-620 administration, relative to surgery, on fluorescence characteristics.

Eligibility criteria:
inclusion criteria: * ductal carcinoma in situ (dcis) or stage i-iii, primary invasive carcinoma of the breast * primary surgical treatment is planned to be a mastectomy or lumpectomy. sentinel lymph node (ln) biopsy or axillary ln dissection (alnd) is planned as part of the subject's therapy. * eastern cooperative oncology group (ecog) performance status of 0-2 * adequate renal function * lab values (hematology and chemistry) within institution's normal laboratory limits * willing to remain on-site for approximately 24 hours after administration of avb-620 or, if required, stay overnight after the surgical procedure * if the subject received neoadjuvant therapy, residual tumor is present (to be determined by the primary surgeon) * if the subject received prior anthracycline therapy, the left ventricular ejection fraction (lvef) must be within institution's normal limits * subject has the ability to understand and the willingness to sign a written informed consent document exclusion criteria: * recurrent ipsilateral breast cancer * prior neoadjuvant chemotherapy or biologic therapy for current clinically or biopsy-proven node positive breast cancer within 4 weeks before the planned surgery. * open surgery in the ipsilateral breast within 1 year of avb-620 administration * history of radiation therapy to ipsilateral breast * abnormal cardiac rhythm not controlled with medication, history of stroke, coronary events, and/or heart failure within 1 year of avb-620 administration * diagnosis of autoimmune disorders * history of drug-related anaphylactic reactions or allergic reactions; subjects with an active diagnosis of uncontrolled airway hyperactivity, uncontrolled asthma, or asthma requiring oral corticosteroids will be excluded * history of renal disease or current evidence of renal disease * current diagnosis of any other active or clinically significant non-breast cancer * systemic investigational drug of any kind within 6 weeks of avb-620 administration * pregnant or breast feeding

Keywords: avb-620 stage i newly diagnosed breast cancer stage ii stage iii ductal carcinoma in situ
probiotics and its associated factors on aflatoxin biomarkers

Conditions: Aflatoxicosis

Summary: the study will be aimed to investigate the effect of probiotic intervention and its associated factors on aflatoxin biomarkers among healthy subjects in serdang and kajang, selangor

the study will be a randomized, double-blind, placebo-controlled, parallel intervention that conducted for 12 weeks and followed-up for 4 weeks among healthy adults under living condition in serdang and kajang, selangor. 164 subjects will be recruited for the intervention study, where 82 subjects will be randomly allocated to the probiotic or placebo group. probiotic and placebo drinks (80 ml) will be prepared in the form of bottle. placebo drink will have similar taste, colour, physical appearance, and nutritional value as probiotic drink but contain no lcs. morning urine samples (15 ml), weight status, and dietary intake will be collected every two weeks from week 0 to week 12 and follow up until week 16 at community centre. whereas, fasting blood samples (5 ml) and physical activity will be collected every four weeks for 16 weeks at the community centre.

Eligibility criteria:
inclusion criteria: * malaysian healthy male or female adults (bmi \ 4.71 pg/mg albumin, and afm1 \> 0.88 ng/ml exclusion criteria: 1. history or presence of any clinically important disease or disorder (eg. cardiovascular disease, kidney disease, diabetes mellitus, etc.) which, in the opinion of the investigator, may either put the subject at risk because of participation in the study, or influence the results or the subject's ability to participate in the study 2. mental status that is incompatible with the proper conduct of the study 3. functional constipation \[based on rome iii diagnostic criteria with a five-point symptoms based diagnosing tool (0=never or rarely, 1=sometimes, 2=often, 3=most of the time, 4=always)\] 4. diarrhoea within 2 months prior to the study start 5. allergic reaction towards probiotic, milk and with gastric problem 6. lactose intolerance 7. use of medications or/and antibiotics 8. use of probiotic, prebiotic and fibre supplements or/and laxatives during the two weeks prior to study start. 9. drug/alcohol abuse (for alcohol 4 times/day or 20 times/week) 10. pregnant 11. reported special diets such as vegetarian, vegan, or macrobiotic 12. festive (eg. ramadan, chinese new year etc) 3 months before and during the study 13. participation in another intervention study one month prior to the present study

Keywords: probiotics aflatoxin biomarkers healthy subjects intervention
effectiveness and safety of electro-acupuncture for mild-to-moderate perimenopausal depression

Conditions: Perimenopause; Depression

Summary: main objective: to compare the effects of electro-acupuncture and escitalopram oxalate tablets on mild-to-moderate perimenopausal depression, and to evaluate the safety of electroacupuncture stimulation.


Eligibility criteria:
inclusion criteria: * conforms to the diagnosis standard of straw-10 for perimenopause, conforms to the diagnosis standard of the diagnostic and statistical manual of mental disorders, fifth edition (dsm-5) for depression, and conforms to the diagnosis standard of the international statistical classification of diseases and related health problems 10th revision (icd-10) f32.0(mild depression) or f32.1(moderate depression); * fisrt attack during perimenopausal period; * hamd-17 score \>7 and \<23; * age ≥45 to ≤55; * no hormone replacement therapy (hrt) or no antidepressant 3 months before into the group; * sign the consent consent, volunteered for this study exclusion criteria: * fail to rule out the possibility of suicide in depression factor of the symptom checklist (scl-90); * application of estrogen, progesterone, selective serotonin reuptake inhibitors (ssris), soybean isoflavone, vitamin e or black cohosh in recent 4 weeks; * allergic to citalopram or escitalopram tablets; * taken the non selective, irreversible inhibitor of monoamine oxidase (maois) in recent 2 weeks; * taken linezolid, pimozide, tryptophane,tramadol, triptans or other drugs that may cause drug adverse reactions in recent 2 weeks; * patient with prolongation of the qt interval or congenital long qt syndrome * taken herbs or products that contain isatin, pilose antler, hawthorn, fleeceflower root, common st.john's wort herb, hypericin; * ovarian dropsy or hysteromyoma with more than 4cm diameter, oophorectomy, or hysterectomy; * mandatory indications of hormonotherapy, such as surgery-induced menopause or osteoporosis; * patient with history of radiotherapy or chemotherapy, or undergoing radiotherapy or chemotherapy; * vaginal bleeding of undetermined origin; * patient with coagulation disorders, or taking anticoagulants such as warfarin, or heparin; * patient with skin diseases, such as eczema,or psoriasis; * serious hepatic insufficiency or serious renal inadequacy; * uncontrolled hypertension, diabetes, or thyroid disease; * diabetic neuropathy, or malignant tumor; * pregnancy intention, in pregnancy or lactation; * regular use of sedative and anti anxiety drugs; * the long-term smoking and/or drinking; * having pacemaker or artificial joint； * electrolyte is disorder, serious heart disease or other potential life-threatening disease patients; * compliance may be poor or fear of acupuncture.
white cell ratios as markers of delirium and outcome in acute ischemic stroke.

Conditions: Delirium; Ischemic Stroke

Summary: the aim of this study was to investigate the role of neutrophil-to-lymphocyte ratio (nlr) and other derived white cell markers as early markers of delirium and outcome after acute ischemic stroke (ais).

delirium is an acute brain disorder, potentially reversible, commonly occurring in patients with acute ischemic stroke. the pathomechanism of delirium is related to neuroinflammatory process and oxidative stress. search for readily available diagnostic marker that will aid clinicians in early identification of delirium is an on-going process. the aim of this study was to investigate the role of neutrophil-to-lymphocyte ratio (nlr) and other derived white cell markers as early markers of delirium and outcome after acute ischemic stroke (ais).

Eligibility criteria:
inclusion criteria: * age \>18 years) * acute ischemic stroke exclusion criteria: * hematology disorders * incomplete laboratory testing * no data regarding follow-up

Keywords: delirium stroke neutrophil-to-lymphocyte ratio nlr mortality
the effect of patients' participation in improving diabetes care

Conditions: Type 2 Diabetes Mellitus

Summary: despite the advent of efficacious medicines, there is a gap between ideal and actual care in the achievement of recommended outcomes among diabetic patients. the study enrolled 429 diabetic patients attending four hmo clinics in israel, two in the northern region and two in the southern region. all clinics were randomly selected from all clinics affiliated with the faculty of health sciences of the ben gurion university. the objective of the study was to compare the effects of a multi-component physician-patient intervention to physician feedback alone on a combined outcome of diabetes, blood pressure and serum lipids control. we hypothesized that in medical practices where physicians have received feedback on quality of care indicators, patients who received a letter encouraging them to discuss a list of important diabetes-related issues with their doctors, would experience better outcomes compared to patients who did no received such a letter.


Eligibility criteria:
inclusion criteria: * known diabetic patients enrolled in the four primary care clinics * age 30 years and older. exclusion criteria: * below age 30 years * type 1 diabetes * spoke neither hebrew nor russian * bedridden or confined to home.
an observational study of xeloda (capecitabine) in patients with metastatic colorectal cancer, colon cancer in the adjuvant setting, advanced gastric cancer or breast cancer

Conditions: Breast Cancer, Colorectal Cancer, Gastric Cancer

Summary: this multi-center observational study will evaluate the use of xeloda (capecitabine) in patients with metastatic colorectal cancer, colon cancer in the adjuvant setting, advanced gastric cancer and breast cancer in routine clinical practice. eligible patients receiving treatment with xeloda according to product label will be followed for up to 10 months.


Eligibility criteria:
inclusion criteria: * patients with metastatic colorectal cancer, colon cancer in the adjuvant setting, advanced gastric cancer or breast cancer who are candidates for receiving xeloda according to product label exclusion criteria: * contraindications according to label and off-label use
management of cytokine storms in severe covid-19 patients with autologous activated platelet-rich plasma therapy

Conditions: Covid19; Sars-CoV-2 Infection; ARDS, Human; Severe covid19

Summary: the positive cases of coronavirus disease-2019 (covid-19) in indonesia has been increasing rapidly since the first case found in march 2020 to date. coronavirus 2 (sars-cov-2) virus disrupts human normal immune system resulting in uncontrolled inflammatory response. based on our research and experience in doing cell therapy for 9 years, activated platelet-rich plasma (prp) produces anti-inflammatory effects in inflammatory condition that is beneficial for tissue regeneration. in this study, we aimed to evaluate the potential of autologous activated platelet-rich plasma (aaprp) and the outcomes for treating severe coronavirus disease-2019 (covid-19) patients in intensive care unit (icu).

prp decreases il-1β, il-6, il-8, and tnfα inflammatory genes expression while also reduces il-1β and tnfα inflammatory cytokines production. prp has also been showed to contain interleukin 1 receptor antagonist (il-1ra), an anti-inflammatory cytokines that suppress il-6 secretion.

Eligibility criteria:
inclusion criteria: * severe covid-19 patient in icu exclusion criteria: * ckd on hemodialysis, hiv positive, hepatitis, pregnant, destroyed lung, cancer

Keywords: aaprp severe covid-19 platelet-rich plasma sars-cov-2 autologous
safety and pk study in 1- to 3- month-old children with bronchiolitis (0476-297)

Conditions: Bronchiolitis

Summary: the purpose of this study is to look at the preliminary safety profile of an investigational drug in children 1 to \< 3 months of age with bronchiolitis.


Eligibility criteria:
inclusion criteria : * active bronchiolitis and a history of bronchiolitis and asthma-like symptoms. exclusion criteria : * anemia or history of any significant illness that will pose additional risk to the patient.
safety study of human neural stem cells injections for secondary progressive multiple sclerosis patients

Conditions: Secondary-progressive Multiple Sclerosis

Summary: this will be a phase i, open, multicenter, international study performed by 3 participating centres across two countries (italy and switzerland). fifteen to 24 patients affected by spms will be enrolled, according to a "standard" phase i design over 18 months. all patients will enter a 3 months run in phase. thereafter they will receive one of four different doses of allogenic hnscs (dose a=5 millions hnscs; dose b=10 millions hnscs; dose c=16 millions hnscs; dose d=24 millions hnscs). following hnscs injection, all spms patients will receive immunosuppression with tacrolimus for 6 months. patients will be clinically followed monthly for 1 year and then every 6 months for the 5 years following the study completion (possibly all life long). mri assessments will be performed monthly for the first 6 months and then every 3 months for 5 years following the study completion.


Eligibility criteria:
inclusion criteria: 1. spms with progressive accumulation of disability after initial relapsing course, with or without disease activity (lublin et al. 2014). 2. edss ≥ 6.5 and ≤ 8 3. edss progression over the 2 years prior to study start of ≥ 1.0 point for patients with edss =6.5 at the time of inclusion , and of ≥ 0.5 points for patients with edss \> 6.5 at the time of inclusion 4. age ≥ 18 and ≤ 60 years 5. failure of best medical treatment as judged by the treating neurologist and declared absence of therapeutic alternatives exclusion criteria: 1. neurological conditions other than ms. 2. psychiatric disorders, severe cognitive decline and personality and relational disorders. 3. history or known presence of significant systemic, infectious, oncologic or metabolic disorders. 4. presence of any other autoimmune disease. 5. chronic infections (hbv, hcv, hiv, tuberculosis). 6. inability to perform mri scans. 7. immunomodulant/immunosuppressive treatments in the last 6 months before inclusion. 8. current participation to other experimental studies. 9. inability to provide informed consent. 10. any contra-indication to lumbar puncture and the surgical procedure (e.g. use of anticoagulants) 11. pregnancy and breast feeding.

Keywords: cell transplantation neural stem cells
a multicenter, randomized, open label trial of a new animal extracted surfactant to treat rds in preterm infants

Conditions: Respiratory Distress Syndrome

Summary: the purpose of this study is to determine the efficacy and safety of the new pulmonary surfactant produced by butantan institute among premature infants with gestational age below 34 weeks with rds, comparing to the pulmonary surfactants commercially available in brazil.

exogenous surfactant replacement therapy has been one of the major advances in the treatment of premature infants with respiratory distress syndrome (rds). it has decreased the mortality among premature infants with rds, determining changes in the children mortality rates among the developed countries. high cost, however, has been a major handicap for its wide use in developing and underdeveloped countries. based on that, butantan institute (sao paulo, brazil) has developed a new porcine pulmonary surfactant preparation at lower production cost. initial animal studies showed similar improvement in lung mechanics and histopathologic findings to those observed with commercially available preparations. comparison(s): the new surfactant developed and produced by butantan institute will be compared to the commercially available pulmonary surfactants in brazil, regarding to the efficiency to maintain a good arterial oxygenation, low airway pressures after treatment, similar mortality rates, and similar rates of complications like bronchopulmonary dysplasia and pulmonary hemorrhage.

Eligibility criteria:
inclusion criteria: * gestational age below 34 weeks * rds diagnosis based on clinical and rds radiographic patterns * need of mechanical ventilation * parental consent exclusion criteria: * age greater than 24 hours * major congenital malformations * unstable hemodynamic status * occurence of seizure during the stay in the neonatal intensive care unit * maternal and/or fetal infection (chorioamnionitis: maternal fever, foul vaginal discharge, fetal tachycardia, uterine tenderness, leukocytosis or leukopenia) or congenital infection

Keywords: respiratory distress syndrome pulmonary surfactant mortality prematurity