Kornimate/medical-research-clean huggingface dataset:
factors affecting dialysis associated fatigue

Conditions: Dialysis; Complications

Summary: the aim of this study is to investigate the factors affecting hemodialysis-associated fatigue and their impact on the physical and emotional well-being of patients. by identifying these factors, investigators can develop effective strategies to reduce fatigue and enhance the overall quality of life for hemodialysis patients.

chronic kidney disease (ckd) is a significant public health issue affecting millions of individuals worldwide. hemodialysis, the most common modality for renal replacement therapy, is a life-sustaining procedure for end-stage renal disease (esrd) patients. despite its benefits, hemodialysis can be associated with various complications, and one of the most commonly reported symptoms is fatigue. hemodialysis-associated fatigue (haf) is characterized by persistent tiredness, lack of energy, and reduced motivation, which significantly impacts the quality of life and functional capacity of patients. several potential factors contribute to haf, including patient-related variables, dialysis-related factors, and comorbidities. understanding the underlying mechanisms and factors contributing to haf is essential for improving the overall care and quality of life of hemodialysis patients. targeted interventions to address fatigue could lead to better adherence to dialysis treatment, reduced hospitalizations, and enhanced overall well-being for this vulnerable patient population. to date, limited research has been conducted on the subject of haf, and the available studies often have small sample sizes and diverse methodologies. therefore, this research aims to delve into the complexities of haf, exploring its prevalence, potential risk factors, and implications for patient outcomes.

Eligibility criteria:
inclusion criteria: * adult hemodialysis patients aged ≥ 18 years * patients on hemodialysis for at least 3 months exclusion criteria: * patients aged \< 18 years * patients with acute kidney injury * patients with cognitive impairment or inability to provide informed consent
a study of ath-1017 in mild to moderate alzheimer's disease

Conditions: Alzheimer Disease; Dementia of Alzheimer Type

Summary: this study is designed to evaluate treatment effects of ath-1017 (fosgonimeton) in mild to moderate alzheimer's subjects with a randomized treatment duration of 26-weeks.

this study is designed to assess the correlation of the functional translational biomarker p300 latency and change in adas-cog11 induced by ath-1017 therapy, over 26-week randomized, double-blind treatment.

Eligibility criteria:
key inclusion criteria: * age 55 to 85 years * mild-to-moderate ad dementia subjects, mmse 14-24, cdr 1 or 2 at screening * clinical diagnosis of dementia, due probably to ad, by revised national institute on aging-alzheimer's association criteria (mckhann, 2011) * reliable and capable support person/caregiver * treatment-free or receiving stable acetylcholinesterase inhibitor (achei) treatment, defined as: * treatment-naïve, or * subjects are on a stable, approved dose of an achei (except for donepezil at 23 mg po) for at least 3 months before screening or * subjects who received an achei in the past and discontinued 4 weeks prior to screening key exclusion criteria: * history of significant neurologic disease, other than ad, that may affect cognition, or concurrent with the onset of dementia * history of unexplained loss of consciousness, and epileptic fits (unless febrile) * subject has atypical variant presentation of ad, if known from medical history, particularly non-amnestic ad * history of brain mri scan indicative of any other significant abnormality * hearing test result considered unacceptable for auditory erp p300 assessment * diagnosis of severe major depressive disorder even without psychotic features * significant suicide risk * history within 2 years of screening, or current diagnosis of psychosis * myocardial infarction or unstable angina within the last 6 months * clinically significant (in the judgment of the investigator) cardiac arrhythmia (including atrial fibrillation), cardiomyopathy, or cardiac conduction defect (note: pacemaker is acceptable) * subject has either hypertension (supine diastolic blood pressure \> 95 mmhg), or symptomatic hypotension in the judgment of the investigator * clinically significant ecg abnormality at screening * renal insufficiency (serum creatinine \> 2.0 mg/dl) * hepatic impairment with alanine aminotransferase or aspartate aminotransferase \> 2 times the upper limit of normal, or child-pugh class b and c * malignant tumor within 3 years before screening * memantine in any form, combination or dosage within 4 weeks prior to screening * donepezil at 23 mg po * the subject has received active amyloid or tau immunization (i.e., vaccination for alzheimer's disease) at any time, or passive immunization (i.e., monoclonal antibodies for alzheimer's disease) within 6 months of screening

Keywords: alzheimer's disease cognition dementia ath-1017 memory loss
telemedicine enhanced asthma management - uniting providers

Conditions: Asthma in Children

Summary: this research study is an innovative school-based program for urban children with moderate to severe persistent or difficult-to-control asthma. the telemedicine enhanced asthma management-uniting providers (team-up) program enhances a school-based, primary care directed asthma program with specialist-supported care to ensure optimal guideline based treatment. this study is a full-scale randomized trial of team-up versus an enhanced care comparison group. primary care physicians (pcp) of all enrolled children (n=360, 4-12 yrs.) will be prompted to initiate directly observed therapy (dot) of preventive asthma medication through school and to make a specialist referral. for children in the team-up group, the specialist visits will be facilitated via telemedicine at school. the telemedicine specialist visit will be scheduled after 4 weeks of initiating dot, in order to allow for accurate guideline-based assessments of medication and care needs once adherence with a daily controller medication is established. there will also be 2 telemedicine follow-up specialist visits to assess the child's response to treatment and make needed adjustments. the study will use the existing community infrastructure by implementing both telemedicine and dot in school, and maintaining collaboration with pcps. blinded follow-ups will occur at 3-, 6-, 9- and 12-months after baseline, and the primary outcome is the comparison of symptom-free days (sfd) at each follow-up time point.


Eligibility criteria:
inclusion criteria: 1. physician-diagnosed asthma (based on parent report with validation from the child's physician). 2. age \>=4 and =\<12 years. 3. residence in the city of rochester and surrounding suburbs, with a. primary residence within the following zip codes: 14445, 14604, 14605, 14606, 14607, 14608, 14609, 14610, 14611, 14612, 14613, 14614, 14615, 14616, 14617, 14618, 14619, 14620, 14621, 14622, 14623, 14624, 14625, 14626. 4. moderate-severe persistent severity (requiring step 3 or higher care) or difficult to control asthma despite therapy (based on age-specific nhlbi guidelines). exclusion criteria: 1. inability to speak and understand english or spanish. (\*parents unable to read will be eligible, and all instruments will be given verbally.) 2. current participation in an asthma study. 3. planning to leave the rochester city school district area in fewer than 6 months. 4. having received asthma specialist care in the prior 3 months. 5. having other significant medical conditions, including congenital heart disease, cystic fibrosis, or other chronic lung disease, that could interfere with the assessment of asthma-related measures. 6. in foster care or other situations in which consent cannot be obtained from a guardian.
polyaxial brace fixing for the treatment of congenital clubfoot

Conditions: Clubfoot

Summary: congenital idiopathic clubfoot (cc) is the fifth most common congenital malformation in children. the ponseti method is an effective protocol for treatment of congenital idiopathic clubfoot. plaster is essential for the ponseti treatment. this paper describes a new brace that can be used for the treatment of clubfoot in newborns and infants instead of plaster.

methods in the orthopedic department of our hospital, 38 infants and newborns, (57 feet) ,all the patients were under the age of 3 months with congenital clubfoot underwent polyaxial braces between jan, 2011 to oct ,2013. polyaxial brace was used for the deformity correction. then, during the following 1-3 years, the dennis braces were used during the night in case of recurrence. prospective follow-up for a mean duration of 25 months (range, 15-36months) was carried out. the efficacy of the treatment was assessed by pirani's scoring system before and after treatment.

Eligibility criteria:
inclusion criteria: 0-6 months infants parents would like to cooperate with the doctors. exclusion criteria: over 6 months.

Keywords: congenital idiopathic clubfoot pirani score infant polyaxial brace
the development of a screening assay by lc-ms/ms to monitor adherence to asthma treatment

Conditions: Asthma

Summary: phase i: to develop and validate laboratory urine and blood test for the detection of medications commonly used in the treatment of asthma phase ii: to test the developed assay in the clinic, to determine its practicality to conduct, and its clinical utility in adherence assessment.

phase i: laboratory based study to develop lc-ms/ms assay of urine / blood to detect presence or lack asthma medication in 50 volunteers with asthma. phase ii: once the test is validated it will be tested in a 100 patients attending the asthma clinics to test its clinical utility. urine and blood samples will be collected from patients at time of clinic attendance to test for asthma medication panel and outcome will determine adherence or non-adherence. clinical outcomes of adherent versus non adherent groups will be compared in terms of asthma control, lung function, biomarkers feno and blood eosinophils, exacerbation frequency and hospitalisation.

Eligibility criteria:
inclusion criteria: 1. aged 18-80 2. able to give valid informed consent 3. prescribed one or more of the medications to be tested 4. able to provide a blood and urine sample 5. able to complete questionnaires in english exclusion criteria: 1. females who are pregnant or lactating. 2. patients known to have any blood borne virus that would render the sample hazardous. this includes hepatitis b, hepatitis c and hiv.

Keywords: asthma medical adherence
efficacy and safety study of a 10% triple virally reduced intravenous immune globulin solution in adult subjects with chronic idiopathic thrombocytopenic purpura

Conditions: Immune Thrombocytopenic Purpura (ITP)

Summary: the purpose of this study is to evaluate whether immune globulin intravenous (human), 10% tvr (triple virally reduced) solution is an effective and safe treatment in patients with chronic idiopathic thrombocytopenic purpura.


Eligibility criteria:
inclusion criteria: * age \>= 18 and \<= 65 years * itp diagnosed at least 6 months prior to study entry by history, physical exam, blood count and blood smear * baseline platelet count of \<= 20 x 10 to the 9th/l determined prior to administration of the study drug on the day of the first infusion * no ivig treatment for itp during the two weeks prior to the first infusion of the study drug * for females of child bearing potential, use of adequate birth control measures during study participation * written informed consent exclusion criteria: * serum values of alt, ast, alkaline phosphatase, and total bilirubin exceeding 2.5 times the upper limit of normal at screening * renal dysfunction defined as serum creatinine greater than or equal to 2 mg/dl at screening * underlying other autoimmune or lymphoproliferative disorder * uncontrolled hypertension * cardiac insufficiency nyha iii and iv, coronary heart disease (chd) nyha iii and iv * malignancy or history of malignancy * documented selective iga deficiency (\<= 10 mg/dl) * treatment with another investigational drug in the four weeks prior to study entry or current treatment with another investigational product * history of severe adverse reactions to blood and/or blood products * pregnancy or lactation * positivity for hiv, or hcv antibodies, or hbsag * history of unresponsiveness to ivig defined as a peak increment in platelet count \<= 20,000/µl coincident with the last ivig treatment course prior to study entry

Keywords: chronic idiopathic thrombocytopenic purpura
multidisciplinary follow-up of patients treated for malignant hematological disease

Conditions: Malignant Hematologic Neoplasm

Summary: the aim of this study is to adjust and test an existing internet-based tool for collecting patient-reported outcome measures and to use the internet-based tool in an multidisciplinary follow-up of patients treated for malignant hematological diseases. the patient-reported outcome measurements will be used in describing the patients' health-related quality of life (hrqol) and to investigate whether the hrqol will increase due to participation in multidisciplinary follow-up.


Eligibility criteria:
inclusion criteria: * patients diagnosed with malignant hematological disease; morbus hodgkin and b- and t-cell disease * patients followed before or after 1. line treatment * patients in stable phase \> 6 months after 1. line treatment * the patients participation in the study must be assessed and decided by the doctor responsible for the patient's course of treatment exclusion criteria: * health conditions which demands close medical monitoring * conditions which compromise the ability to understand the study and submit informed consent (ex.: dementia and severe mental illness / disability) * lack of capability to fill out electronic questionnaires * poor self-care and/or compliance

Keywords: patient-reported outcomes, health-related qol, internet-based tool
drug use investigation for allermist

Conditions: Rhinitis

Summary: to investigate possible problems or questions in safety and efficacy of allermist nasal spray in japanese subjects with allergic rhinitis under the practical use conditions


Eligibility criteria:
inclusion criteria: * diagnosis of allergic rhinitis * use allermist for the first time * expected to use allermist for long-term (1 year) exclusion criteria: * subjects with infection which fluticasone is not effective * subjects with deep mycosis * subjects with hypersensitivity to fluticason
ai prediction for proximal humeral fractures

Conditions: Proximal Humeral Fracture

Summary: our smartphones can recognize the pictures of our family, loved ones and friends. face recognition software leverages artificial intelligence (ai), image recognition and other advanced technology to map, analyze and confirm the identity of a face. we humans do a poor job when classifying the injury related to a patient sustaining a proximal humeral fracture. in consequence, there is great heterogeneity in the treatment of proximal humerus fractures. moreover, offering relevant information to patients regarding the risk of complications or fracture sequelae is challenging, given that the current series are based on obsolete classifications, and the published series bring together just over hundreds of patients analyzed. with these limitations, patients have few opportunities to participate in decision-making about their injury. the present project aim is to integrate new technologies for the prediction of relevant clinical results for the patients presenting a proximal humeral fracture. in brief, ai can help identify similar fracture patterns without human inference, while humans can feed the algorithm with variables of interest such as the functional outcomes and complications related to this particular type of fracture.


Eligibility criteria:
inclusion criteria: patients sustaining a proximal humerus fracture treated nonoperatively under the criteria of the treating surgeon and patients' preference. subjects evaluated within the first 3 weeks after the injury. patients between 18 and 90 years of age. patients who have been studied with simple shoulder radiographs in anteroposterior and scapular outlet projections. participants who accept 1-year time follow-up. exclusion criteria: patients with dementia or difficulty completing the evaluation after one year of follow-up. patients who have previously received surgical treatment on the affected limb. patients who have suffered a previous fracture in the affected limb. surgically treated patients.
the effectiveness and safety of topiramate on prevention of chronic migraine

Conditions: Migraine

Summary: the purpose of this study is to evaluate the safety and effectiveness of individualized doses (50 to 200 milligrams) of topiramate tablets compared against placebo for the prevention of chronic migraine headaches over a period of 16 weeks.

previous studies have shown that topiramate is effective in preventing chronic migraine headaches. this study will start with a 4-week baseline period in which no treatment is given, followed by a 12-week period in which each patient's dose is adjusted and then kept stable for the last 4 weeks of the 16-week double-blind phase. the individualized dose will start at 25 milligrams of topiramate per day and will be increased 25 milligrams per day once weekly and then raised to either the target--100 milligrams per day--or the maximum dose that is well tolerated up to 200 milligrams per day. patients who are randomized to receive topiramate will remain on the optimized dose. the comparison phase of the study is a 16-week period in which the change in migraine days of patients on topiramate (taking at least 50 milligrams per day) is compared with the change in migraine days for patients on the placebo. also studied will be the patients' health-related quality of life as assessed by questionnaires filled out at specific visits as well as the patients' views of the safety and tolerability of topiramate. the study hypothesis is that the number of migraine days, periods, and attacks from the baseline period to the last 4 weeks in the double-blind period is reduced more in the topiramate group than the placebo group. during the 16-week comparison period, patients will take by mouth a dose of 50 milligrams to 200 milligrams of topiramate daily.

Eligibility criteria:
inclusion criteria: * history of migraine for \>= 1 year * headache type meets his (international headache society) criteria for migraine * history reflects "chronic" headache--an average of \>= 15 migraine days per month in the 3 months preceding trial entry * history of chronic migraine for \>=1 year\>=15 headaches per month with an average duration of 4 hours if not treated * patient is otherwise neurologically and physically healthy on a pre-trial exam. exclusion criteria: * any other type of chronic headache (besides migraine) from section 2 to 13 of the international headache society classification or headache resulting directly resulting some other factor (except for medication overuse) * onset of migraine after age 50 * use of an anticonvulsant drug in the month prior to trial entry * use of an antidepressant unless dose has been used at a stable dose for \>=3 months * use of migraine prevention medicine in the 3 months prior to trial entry unless the drug has been used for at least 3 months and used at a stable dose for at least a month * use of a carbonic anhydrase inhibitor such as acetazolamide (used to treat high blood pressure, glaucoma and seizures) or triamterene (a "water pill" for swelling and high blood pressure).

Keywords: chronic migraine migraine headache migraine headache topiramate
ulinastatin in inhalation lung injury

Conditions: Inhalation Injury

Summary: the purpose of this study is to evaluate the efficacy and effect of ulinastatin in inhalation lung injury patients.


Eligibility criteria:
inclusion criteria: * moderate to severe inhalation lung injury * within 48hours after inhalation injury * age 18 to 70 years old * burned area not more than 70% tbsa * signed the informed consent form exclusion criteria: * pregnancy or lactation * allergy for ulinastatin * received an investigational drug or device within 90 days prior to entering study

Keywords: ulinastatin inhalation injury
prospective comparison between sadi-s and gastric bypass

Conditions: Morbid Obesity; Diabetes

Summary: patients with bmi over 40 or with bmi over 35 and comorbidities are offered sadi-s with a variable limb length between 250 cm and 300 cm or gastric bypass. results on weight loss, comorbidities resolution, complications, re-operations, need of supplements are registered.

morbid obese patients and patients with an initial bmi over 35 with associated comorbidities - as diabetes mellitus - are evaluated for bariatric surgery. candidates are offered a standard gastric bypass or a single anastomosis duodeno-ileal bypass with sleeve gastrectomy. patients with higher bmi and those with worse metabolic condition are encouraged to accept the malabsorptive option. gastric bypass is performed with a 150 cm alimentary limb and a calibrated pouch and anastomosis over a 14 mm bougie. sadi-s is performed with a sleeve gastrectomy over a 54 french (18 mm) gastric bougie and a 250 cm common limb. patients are managed equally during admission: 6 hours to initiate oral intake, 2 days to remove abdominal drain and 3 days to discharge unless contraindicated. follow up is performed through visits every 3 months the first 2 postoperative years and every 6 months from the 3rd to the 5th year.

Eligibility criteria:
inclusion criteria: * morbid obesity exclusion criteria: * drug addiction * alcoholic * neoplasms * immunosuppression * mental diseases

Keywords: obesity, malabsorption, gastric bypass, sadi-s