Kornimate/medical-research-clean huggingface dataset:
biospecimen analysis in detecting chemical concentrations in patients with chronic or infectious diseases receiving meditations

Conditions: Chronic Disease; Infectious Disorder

Summary: this trial collects and analyzes sweat and saliva samples compared to blood in detecting chemical concentrations in the body in patients with chronic or infectious diseases receiving medications. wearable sweat sensors are capable of monitoring electrolytes and metabolites (sodium, potassium, glucose, lactate, etc.) for health monitoring and disease diagnosis. designing wearable sweat sensors capable of providing information regarding drug administration may be challenging due to ultralow concentrations in biofluids. this trial seeks to determine if the use of a smart wristband can accurately measure the levels of chemicals and substances in sweat.

primary objective: i. to compare novel, home-based methods of quantitating medication concentrations in either saliva or sweat to the 'gold standard' of liquid chromatography - mass spectrometry of plasma. secondary objectives: i. to compare novel home-based methods of quantitating substances in either saliva or sweat to the 'gold standard' in plasma. ii. assess the ease of obtaining home-based samples. outline: patients undergo collection of sweat samples via macroduct sweat collection system 3710s and saliva and blood samples within 24 hours after medication administrations. patients also complete questionnaires over 5-10 minutes and have medical charts reviewed. after completion of study, patients are followed up periodically.

Eligibility criteria:
inclusion criteria: * scheduled to receive medications including, but not limited to, cyclophosphamide, mycophenolic acid, mycophenolate mofetil, metformin or busulfan (any dose, any number of doses, any dosing frequency) as part of treatment at any time. patients with chronic or infectious diseases can participate * willingness to: * provide blood, sweat, and saliva samples * permit medical record review exclusion criteria: * pilocarpine allergy * difficulty with understanding written english
a multi-site hybrid type i effectiveness-implementation randomized trial of an emergency care action plan for infants with medical complexity

Conditions: Chronic Disease Management; Infants Health; Emergency; Utilization, Health Care; Caregiver Stress

Summary: infants with medical complexity (imc) are a challenging population with more emergency department visits, inpatient stays, and higher healthcare costs than other children. imc also experience lower quality emergency health care. the pi and team propose to adapt and put into place an emergency care action plan (ecap) for imc across four us hospitals, working directly with medical providers and families in each setting. after the tool is made available to providers and families, the pi and team will measure if the ecap tool helps decrease the number of hospitalizations (primary research outcome) for imc, as well as if the ecap is feasible, acceptable, and useable for those using the ecap over a one-year period.

the project goal is to optimize and implement an emergency care action plan (ecap) developed previously by the pi and team (through an nih k23 award) to improve emergency care for infants with medical complexity, a particularly challenging subset of cmc with high utilization and unique challenges in the acute care setting. dr. pulcini and team will conduct a hybrid type i effectiveness-implementation randomized trial of the ecap at four sites (children's hospital colorado, cincinnati children's hospital medical center, children's hospital of philadelphia, and the university of vermont), measuring both health care outcomes/effectiveness (primary endpoint: number of hospitalizations) and implementation (endpoints include acceptability, feasibility, and useability). dr. pulcini and team will also measure key secondary health service measures (ex. ed visits, caregiver stress and self-efficacy) and monitor facilitators and barriers to implementation throughout the trial at each site.

Eligibility criteria:
inclusion criteria: * age 0 to 6 months * admitted to the university of vermont medical center, cincinnati children's hospital, children's hospital of philadelphia, or colorado children's hospital neonatal intensive care unit (nicu), * meets or is expected to meet children with medical complexity status as determined by the treating nicu clinician and defined as "children with multiple significant chronic health problems including multiple organ systems, which result in functional limitations, high health care needs or utilization, and often require need for, or use of, medical technology." * has three or more documented complex chronic conditions (cccs) exclusion criteria: * does not have a caregiver participant who agrees to their participation in the study to complete follow-up surveys * does not intend to use the hospital or affiliated sites of which they were recruited from for care during the one-year trial period

Keywords: children with medical complexity hybrid implementation trial health service utilization
omission of axillary lymph node dissection in case of tumor spread to lymph nodes in the armpit in breast cancer

Conditions: Breast Carcinoma; Breast Cancer; Breast Surgery

Summary: senomac-ultra enrols patients with breast cancer that has spread to lymph nodes in the armpit, and that have been detected already prior to surgery by imaging, e.g. ultrasonography. in this situation, a full axillary lymph node dissection, removing more than 10 lymph nodes from the arm pit, is unnecessarily extensive in about half of the patients. more extensive surgery leads to a risk for arm lymphedema and functional problems with the arm and shoulder region, which should be avoided if not beneficial for diagnosis or prognosis. this trial seeks to ascertain that less extensive surgery, performed by only removing the first lymph node/s in the armpit (the sentinel lymph node/s) and the known metastatic lymph nodes, offers non-inferior survival outcomes to a full axillary lymph node dissection.


Eligibility criteria:
inclusion criteria: * patients with primary invasive breast cancer ct1-t3 * axillary metastases detected by ultrasound (other imaging accepted if confirmatory ultrasound is performed) * axillary metastasis confirmed by fine needle or core biopsy * written informed consent * age ≥ 18 years exclusion criteria: * distant metastases * nodal metastases in ipsilateral axillary levels 3 or 4 * preoperative suspicion of extensive nodal involvement, i.e. locally advanced disease * clinically n2-3 disease on palpation or imaging (i.e. nodes fixed to each other or to neighbouring structures) * history of prior invasive breast cancer * bilateral invasive breast cancer * pregnancy or breast-feeding * neoadjuvant systemic treatment (short course of neoadjuvant endocrine therapy \<three months is allowed) * medical contraindications for radiotherapy or the recommended adjuvant systemic treatment which complies with standard of care, taking age and comorbidity into consideration * inability to absorb or understand the meaning of the study information; for example, through disability, inadequate language skills or dementia

Keywords: axillary metastases axillary lymph node dissection targeted axillary dissection sentinel lymph node biopsy axillary ultrasonography
dysthymia: associated costs, treatment and change process

Conditions: Depression; Cost Benefit Analysis; Psychotherapeutic Processes

Summary: the study evaluates cost and effect of inpatient versus outpatient treatment of dysthymia, as well as investigates the processes through which psychotherapy works in treating dysthymia.

inpatient treatment allows a more intensive treatment and allows the patient to be in a context where it is possible to focus on the processes in therapy with minimal interruption. outpatient treatment is much less intensive but allows the treatment process to unfold in the context where the patient is experiencing the problems that brought them to therapy. it is not clear which of the contexts will be more effective in alleviating symptoms of dysthymia. further, as dysthymia is a very costly disease for society it is of interest to know if the two treatments are cost-effective, and which one is the most cost effective. a great paucity on dysthymia research ha left the psychotherapy field without an understanding of the processes through which dysthymia is changed. this study will investigate the change process through frequent assessments of common factors, psychological processes, symptoms, heart rate variability and cognitive attention bias.

Eligibility criteria:
inclusion criteria: * inclusion criteria will be liberal and similar to clinical practice criteria at the treatment site: persistent depressive disorder as defined by the diagnostic and statistical manual of mental disorders (dsm5); which includes an international classification of disorders-10 (icd-10) diagnosis of depression, dysthymia, recurrent depression. unsuccessful previous treatments. living within driving distance from the treatment facilities. exclusion criteria: * current suicidal risk, current psychosis, marked emotional instability (i.e. issues with impulsivity), strong paranoid traits, current problems related to heavy substance abuse.

Keywords: dysthymia persistent depressive disorder chronic depression recurrent depression
effect of fenofibrate on sleep apnea syndrome

Conditions: Dyslipidemia; Sleep Apnea Syndrome; Overweight; Obesity

Summary: objectives: to investigate for the potential effect of fenofibrate on symptoms and biological changes associated with sleep apnea syndrome.


Eligibility criteria:
inclusion criteria: * having previous diagnosis of sleep apnea not treated with continuous positive airway pressure (cpap) or presenting clinical symptoms of sleep apnea * overweight or obese, with bmi \>= 25 kg/m² and \< 40 kg/m². * known moderate hypertriglyceridemia, with fasting triglycerides level \>= 2.0 and \< 6.0 mmol/l within 3 months before the inclusion. exclusion criteria: * indication for immediate cpap * other known endocrine disease, except treated and adequately controlled hypothyroidism * renal failure or plasma creatinine level \>130 µmol/l * current chronic liver disease or alanine amino transferase (alt)\> 2 times the upper normal limit (unl) * symptomatic gallbladder disease * known muscular disease or creatine phosphokinase (ck) \> 3 times unl.

Keywords: dyslipidemia sleep apnea syndromes fenofibrate obese overweight or obese patients
evaluation of the efficiency of treatment by bumetanide on autistic children with a known ethiology

Conditions: Autistic Disorder

Summary: during a previous therapeutic trial, investigators showed that the bumetanide improved significantly autism. this trial showed that a therapeutic response was obtained in 75% of cases. these first results were reinforced by a study led with adult patients for whom the eye tracking measurements as well as the functional mri showed a diminution of the response time and a modification (amplification) of the cerebral response during an emotions recognition test. finally, investigators confirmed the physiological mechanism behind the action of the bumetanide in a study in two mouse models of autism.


Eligibility criteria:
inclusion criteria: * children and teenager from age 5 to age 17, with a diagnosis of typical autism or asperger syndrome according to the criteria of diagnosis of the who's classification (cim-10), * with a known etiology, * patients for whom the cars results are strictly superior or equal to 30, * of whom the parents have given their free, informed and written consent, * affiliated or beneficiary of the french social security. exclusion criteria: * patients under treatment by inlet diuretic either at the time of the study or before, * patients with electrolytic disorders, * patients with a known hypersensitivity to sulfa drugs, * patients with a hepatic or renal failure, * patients with an epilepsy not controlled by a treatment (comitial crisis in the past 6 month at the time the trial starts despite a treatment), * patients under treatment by psychotropic exception made of the melatonin, * allergy to the bumetanide or one of its excipients, * patient under a treatment by lithium, diphemanil, erythromycin iv, halofantrine, pentamidine, sultopride, vincamine, aminoglycoside, * pregnant and lactating women. secondary exclusion criteria: * qt prolongation noticed on the ecg at day0, * anomaly on the biological check up (day 0) made before including the patient that would contraindicated the prescription of bumetanide, * patients for whom the cars results are strictly inferior to 30.

Keywords: autism, bumetanide
parenteral nutrition cycling for prevention of cholestatic syndrome in newborn

Conditions: Cholestasis in Newborn

Summary: background: despite the use of parenteral nutrition cycling (pnc) in neonatal intensive care units (nicu), there is limited evidence regarding the benefits in relation to the nutrición parenteral total (npt) in term and late preterm infants. the recommendations from the recently published latin american society of gastroenterology, hepatology and pediatric nutrition guidelines are substantially different in this area, and surveys have reported variations in clinical practice. the aim of this randomised controlled trial (rct) is to evaluate the benefits and risks of pnc and parenteral nutrition total (npt) in term and late preterm infants.

methods/design: this study is a single-centre, non-blinded rct in the nicu of pediatric hospital of sinaloa, northwest, mexico. a total of 66 infants born ≥34 weeks of gestation who have a high likelihood of intolerance to enteral nutrition (en) for at least 10 days will be randomised to pnc o pnt after informed parental consent. in both groups, en will be commenced as early as clinically feasible. primary outcomes incidence of colestasis on day 28 of admission. secondary outcomes are total plasma bilirrubine profiles, the incidence of hypoglycemia, hospital-acquired infections, length of hospital/nicu stay, in-hospital all-cause mortality, weight, height and head circumference. discussion: this rct will examine the effects of nptc versus late pnt in term and late preterm infants by comparing key biochemical and clinical outcomes and has the potential to identify underlying pathways for beneficial or harmful effects related to both treatments. trial registration: 2022.hps.di.434 (3rd march 2024) keywords: parenteral nutrition cycling, incidence of colestasis, incidence of hypoglycaemia, hospital-acquired infections, randomised controlled trial.

Eligibility criteria:
inclusion criteria: * chylothorax * intestinal obstruction * intestinal malrotation * intestinal intussusception * gastroschisis * intestinal volvulus * duodenal atresia * enterocolitis * sepsis * septic shock * prolonged fast * authorization of the study by parents exclusion criteria: * presence of liver diseases or malformations that cause cholestasis. * all patients who have received medical treatment for cholestasis are excluded.

Keywords: parenteral nutrition cycling incidence of colestasis incidence of hypoglycemia hospital-acquired infections randomised controlled trial
current treatment modalities for wide necked intracranial aneurysms

Conditions: Brain Aneurysm

Summary: * give an effective treatment for intracranial wide necked aneurysm and can detect the best method could be used. * improve the outcome of these patients and decease rate of recurrence and complications.

the prevalence of intracranial aneurysms in the adult population is estimated to be around 2 %. most remain asymptomatic, but there is a risk of rupture of 1.2 % per year, and this risk increases in line with the diameter of the aneurysm. if rupture occurs, subarachnoid hemorrhage and its associated acute complications are responsible for high mortality (between 30 and 67 %) and morbidity (between 15 and 30 %). coil embolization of intracranial aneurysms has made remarkable technological progress since the international subarachnoid aneurysm trial (isat) data were released in 2005. however, wide-necked aneurysms remain a great challenge to be treated via the endovascular means, as they are associated with a significantly greater incidence of adverse events when compared with narrow-necked ones. acutely ruptured wide-necked intracranial aneurysms pose technical challenges to the treating physician; thus, multiple endovascular techniques have been described to treat these lesions, including balloon-assisted coil placement, double microcatheter technique, and microcatheter assisted coil placement. however, the use of these techniques can sometimes be limited, owing to the lack of permanent support for the coil mass inside the aneurysm sac, which may lead to coil prolapse or migration after the procedure, especially for wide-necked aneurysms (dome-to-neck ratio is less than 1) or tiny aneurysms (3 mm). therefore, surgical clipping is preferred for acutely ruptured wide-necked intracranial aneurysms in most institutions. surgery, however, may also be challenging in some of these lesions, since clips may slip, and surgical access may be limited because of the swelling of the brain in the acute setting of a subarachnoid hemorrhage. flow diverters are new implantable medical devices that make possible to embolize wide-necked aneurysms without the use of coils; the efficacy results published to date are encouraging in terms of complete occlusion in the medium-term, thereby confirming the innovative nature of the flow diversion technique that we aim to evaluate without the use of coils.

Eligibility criteria:
inclusion criteria: • patients who undergo surgical clipping or any endovascular techniques used in treatment of wide-necked intracranial aneurysms. wide-necked aneurysms are defined as aneurysms with a fundus-to-neck ratio of less than 2 or a neck diameter of 14 mm. exclusion criteria: * patients with narrow-necked intracranial aneurysms * patients who are unfit for any neurosurgical interventions. * patients who had artery aneurysm and vascular malformation due to some trauma.

Keywords: wide necked intracranial aneurysms
the performance of patient support program in early stage breast cancer

Conditions: Breast Cancer

Summary: the purpose of this study is to compare the 1-year adherence to upfront adjuvant ai for postmenopausal, early stage breast cancer in the two observational arms; standard treatment and standard treatment plus psp arm after one year


Eligibility criteria:
inclusion criteria: * provide signed and dated written informed consent * have been taking upfront ai adjuvant therapy in line with current smpc * be capable of completing drug intake by herself * be capable of understanding chinese exclusion criteria: * upfront adjuvant hormonal therapy by an ai to which upfront adjuvant indication has not been granted by sfda * upfront adjuvant ai medication which has exceeded over eight weeks * previous adjuvant hormonal therapy for breast cancer lasting over 8 weeks other than ai * involvement in the planning and conduct of the study (applies to both astrazeneca staff or staff at the study site)

Keywords: psp standard treatment standard treatment plus psp
institut paoli calmettes chronic lymphatic leukemia database

Conditions: Leukemia, Lymphocytic, Chronic, B-Cell

Summary: database of institut paoli-calmettes patients diagnosed with chronic lymphatic leukemia


Eligibility criteria:
inclusion criteria: * diagnosis of chronic lymphatic leukemia exclusion criteria: * score of matutes \<4
creation of the biobank, early detection and discovery biomarkers

Conditions: Pancreatic Cancer; Head and Neck Cancer; Breast Cancer

Summary: to establish a multidisciplinary research structure for tissue repository that facilitates projects that bridge specialties that normally may or may not interact.

to establish a multidisciplinary research structure that facilitates projects that bridge specialties that normally may or may not interact. the tissue bank will build the platform for a novel application of translational research that links cutting edge molecular laboratory techniques to clinical outcome studies in a fast and direct manner. tissue banks can be used for numerous discovery applications such as the identification and structural characterization of human genes, expression analysis, or discovery proteomics. biological specimens, when coupled with standardized treatment and outcome data, will be essential resources for the identification, characterization, and validation of biomarkers that are predictive of disease and treatment.

Eligibility criteria:
inclusion criteria: * male and female volunteers exclusion criteria: * n/a volunteers

Keywords: tissue bank
pilot open-label trial of resistant potato starch in patients with cirrhosis and overt hepatic encephalopathy

Conditions: Hepatic Encephalopathy; Cirrhosis

Summary: this research is studying how a food product (resistant potato starch) which is a dietary supplement made from potato starch affects the gut bacteria of people with cirrhosis and hepatic encephalopathy. the researchers in this study want to understand how potato starch works in the subject's body and how the body will react to it. along with taking the study product participants health-related information and stool will be collected for this research study.


Eligibility criteria:
inclusion criteria: * able to provide consent, with signed and dated informed consent form. * stated willingness to comply with all study procedures and availability for the duration of the study. * diagnosis of cirrhosis based on liver biopsy, imaging, or evidence of clinical decompensation. * history of at least one episode of overt hepatic encephalopathy (he) in the last year. * defined by west haven criteria grades ii to iv * can be precipitated hepatic encephalopathy (he) episode. * sexually active women of childbearing potential enrolled in the study must agree to use a highly-effective method of contraception (defined in the protocol) for the duration of the study. exclusion criteria: * hospitalization in the last 4 weeks * current refractory ascites (requiring large volume paracentesis to manage ascites) * gut-absorbable or intravenous antibiotic therapy in the last 4 weeks (rifaximin is permitted) * anticipated antibiotics in the coming 4 weeks * use of lactulose in the last 4 weeks * alcohol or illicit drug intake in the last 4 weeks * by history * alcohol use will be characterized as \>1 alcoholic drink / week * history of inflammatory bowel disease * history of primary sclerosing cholangitis * total bilirubin in the last 3 months \> 4 mg/dl * prior diagnosis of dementia or other primary neurocognitive disorder * pregnancy or breast feeding * placement of a portosystemic shunt or transjugular intrahepatic portosystemic shunt in the last 3 months (permissible if placed \>3 months before enrollment) * allergy to resistant potato starch

Keywords: resistant potato starch