Kornimate/medical-research-clean huggingface dataset:
renal prognosis in chronic kidney disease patients with hyporesponsive anemia to erythropoiesis stimulating agents

Conditions: Renal Anemia; Chronic Kidney Disease

Summary: this is an observational clinical research on patients with chronic kidney disease who are not on hemodialysis and receiving darbepoetin alfa to treat diagnosed renal anemia; the major objective is to explore novel erythropoiesis stimulating agent (esa) response index in association with deterioration of renal function as well as occurrence of cardiovascular disease events.


Eligibility criteria:
inclusion criteria: 1. patients who are planning to start treatment with darbepoetin alfa within 8 weeks after enrollment, 2. patients with egfr \<60 ml/min/1.73m2 at the latest examination performed within 8 weeks before enrollment, 3. patients with a hemoglobin level \<11.0 g/dl at the latest examination performed within 8 weeks before enrollment, 4. patients aged at least 20 years or older at the time of providing informed consent, 5. patients who voluntarily provided written informed consent to participate in the study. exclusion criteria: 1. patients who are planning to start hemodialysis or to have a renal transplant within 24 weeks after enrollment, 2. patients with a history of treatment with esa except the ones who were treated temporarily more than 12 weeks before the enrollment, 3. patients with malignant tumor, hematological disease, or hemorrhagic lesions, 4. patients with hypersensitivity to esa or any ingredient thereof, 5. pregnant, lactating or possibly pregnant women or those who wish to become pregnant during the study period, 6. patients who are participating in other clinical study, 7. patients who are assessed as not eligible for the study by the investigator.

Keywords: chronic kidney disease erythropoiesis stimulating agent response index hyporesponsive anemia to erythropoiesis stimulating agent observational study
a new birth weight prediction in chinese population

Conditions: Birth Weight

Summary: to determine the value of principal component analysis in the combined method of three-dimensional ultrasonography assessing fetal limb volume and circumference and conventional two-dimensional ultrasonography for prediction of birth weight in southern chinese population.

a prospective study was performed on single pregnant women in third trimester. three- and two-dimensional ultrasonography for fetal biometric parameters were measured within 7 days of delivery. stepwise linear regression were used to develop a new prediction model based on values from limb parameters and traditional measurements in development group. estimated and actual birth weight were compared between the new model and previously published formulas on absolute error and percentage error. the accuracy of the model in predicting fetal birth weight was reassured by validation group.

Eligibility criteria:
inclusion criteria: * the inclusion criteria consisted of well-defined gestational age (ga), singleton pregnancy and delivery in our hospital within 7 days from the scan performed for acquisition of 2d and 3d ultrasonographic data. exclusion criteria: * the exclusion criteria were equivocal ga, multiple pregnancy, fetal severe malformation detected by prenatal ultrasonographic scans, delivery more than 7 days after the scan of 2d and 3d ultrasonography, and delivery in other institutions.

Keywords: birth weight prediction two-dimensional ultrasonography three-dimensional ultrasonography
effect of velphoro on serum phosphate and albumin in peritoneal dialysis patients

Conditions: Peritoneal Dialysis Complication; Hyperphosphatemia; Hypoalbuminemia

Summary: prospective pilot study to determine if changing the phosphate binder to sucroferric oxyhydroxide for for 6 months improves disordered mineral metabolism and nutrition status in peritoneal dialysis patients.


Eligibility criteria:
inclusion criteria: * age ≥ 18 years * on peritoneal dialysis at least 3 months with a kt/v of ≥ 1.7 * use of automated peritoneal dialysis * serum phosphate \> 5.5 mg/dl or \<5.5 mg/dl on a binder other than velphoro * serum albumin ≤ 3.7 g/dl * able to provide consent * ability to complete self-reported questionnaire exclusion criteria: * inadequate dialysis * current use of sucroferric oxyhydroxide * significant comorbid conditions that lead the investigator to conclude that life expectancy is less than 6 months * active malignancy * recent episode of peritonitis * pregnancy or planning to become pregnant * anticipated kidney transplantation within 6 months * factors judged to limit adherence to interventions * known adverse side effect to sucroferric oxydroxide
epidiolex and drug resistant epilepsy in children

Conditions: Epilepsy

Summary: this open-label, multi-center study is open to patients 1 to 18 years of age at time of enrollment with medication resistant epilepsy.

this open-label, multi-center study is open to patients 1 to 18 years of age at time of enrollment with medication resistant epilepsy. the study consists of an 8 week baseline, titration, and treatment of epidiolex in a daily dosage up to 25 mg/kg/day, with an optional secondary titration schedule after 26 weeks of treatment up to a maximal daily dosage up to 50 m/kg/day until end of treatment, followed by a taper-down period, and a safety follow up. treatment will be provided for a total of 52 weeks with an interim analysis conducted 12 weeks after achieving maximal dose (either 25 mg/kg/day or optimal dose with regards to safety and tolerability) and at the end of 1 year of treatment with treatment extensions conducted beyond 52 weeks until such time as there is market authorization for epidiolex, if epidiolex becomes unavailable, or the study is terminated. cessation of epidiolex administration will be concluded with a taper period and follow-up visit 4 weeks after the taper.

Eligibility criteria:
inclusion criteria: * patient should have history of trying at least four antiepileptic drugs (aeds), including one trial of a combination of two concomitant drugs, without successful seizure control. vagal nerve stimulation, rns deep brain stimulation, or the ketogenic diet can be considered equivalent to a drug trial. * patient must be taking two or more aeds at a dose which has been stable for at least four weeks. * a state of georgia resident. exclusion criteria: * patient is diagnosed as having dravet syndrome or lennox-gastaut syndrome and eligible for a gw pharmaceutical-sponsored clinical trial. * patients who have been part of a clinical trial involving another investigational product in the previous six months.
compassionate communities neighbourhood program

Conditions: Chronic Disease; Aging

Summary: this study will evaluate a compassionate communities-based intervention aimed at reducing social isolation by mobilizing individuals to act on their health and social needs individually, and in collaboration with fellow members of their community. the intervention program includes facilitated building of neighbourhood networks (member benefits include access to practical help, the opportunity to develop meaningful relationships, and community mobilization), and coaching support to work on individualized goal setting and more detailed navigation support and planning.

the compassionate communities intervention is catalyzed by professional facilitators who visit communities with high concentrations of elderly and vulnerable residents, and recruit those who are interested in a project to identify their own health and social needs, assets and priorities; to collectively work to support each other in achieving these; and to implement a neighbourhood exchange to more easily match offers of help to people who need help. the mobilization work starts with the facilitator, who is employed by a community or social service organization, but increasingly draws on the energies of the mobilized initial participants as volunteers who conduct further community outreach in their community, attracting and mobilizing other residents, peers, and neighbouring resources in the work. participants also plan and implement a broad range of activities identified by the residents as their priorities for neighbourhood building. participants and their caregivers have the option of receiving more in-depth 1:1 coaching support to work on individualized goal setting, more detailed navigation support or advanced care planning following the sessions.

Eligibility criteria:
inclusion criteria: * seniors (65 years of age and older) * people with disabilities * caregivers of seniors or people with disabilities * residing in identified buildings/ neighbourhoods where the weccc compassionate communities neighbourhood program is being launched * able to communicate in english or interpreter can be arranged exclusion criteria: * not able to communicate in english and interpreter cannot be arranged

Keywords: disability
software-delivered cbt-i for insomnia disorder

Conditions: Insomnia Disorder

Summary: the goal of this prospective multicenter clinical trial is to evaluate the efficacy and safety of software-delivered cognitive behavioral therapy for insomnia (cbt-i) in chinese patients with insomnia disorder (id). the main questions it aims to answer are: (1) whether the software-delivered cbt-i is more effective than an online patient education (online-pe) at improving insomnia. (2) whether the software-delivered cbt-i is safe for treatment of insomnia symptoms. participants will be randomized to receive (1) a software-delivered cbt-i using automated software called 'resleep' (one kind of digital device expected to treat insomnia targeted for chinese patients); (2) online patient education (online-pe) about sleep. researchers will compare the efficacy of a software-delivered cbt-i program and an online sleep education control at improving insomnia symptoms and other psychological outcomes.


Eligibility criteria:
inclusion criteria: * aged ≥18 years old, no gender limitation; * own a mobile-phone, access the internet, and be skilled in using software; * meet the diagnostic criteria of insomnia disorder in the diagnostic and statistical manual of mental disorders (fifth edition) (dsm-5); * insomnia symptoms appear at least 3 nights per week and last for at least 3 months; * isi scores ≥ 12 ; * volunteer to participate in this experiment and sign a written informed consent. exclusion criteria: * generalized anxiety disorder scale-7 (gad-7) scores ≥ 15; * patients health questionnaire-9 (phq-9) scores ≥ 20; * current thoughts of suicide or self-injury (defined as phq-9 9th item score ≥ 1); * confirmed physical diseases that may affect sleep, such as congestive heart failure, chronic obstructive pulmonary disease acute phase, cardiovascular and cerebrovascular disease acute phase, etc. * current diagnosed neurological or mental illness (major depressive disorder, bipolar disorder, epilepsy, schizophrenia, etc.) that may affect sleep; * diagnoses of other untreated sleep disorders, such as obstructive sleep apnea, restless leg syndrome (rls); * usual bedtime (when the subject attempts to fall asleep) is earlier than 8 p.m. or later than 2 a.m., or usual waking (arising) time is earlier than 4 a.m. or later than 10 a.m. * alcohol or drug abusers (other than nicotine dependence) in the past year; * pregnant or lactating women; * undergoing systematic psychotherapy within the past 3 months; * undergoing other cognitive behavioral therapy for sleep disorders; * unstable usage of medication regimens that affect sleep (changes in type, dosage and method of use within the past 1 month); * night shift workers, travelers across time zones; * subjects who have not responded to previous cbt-i; * other conditions deemed unsuitable for clinical trials by the investigator.

Keywords: insomnia disorder software-delivered cbt-i randomised clinical trial digital therapy
stavanger university hospital inflammatory bowel disease trial

Conditions: IBD

Summary: the study aims at studying the outcomes of a protocol-based handling of newly diagnosed inflammatory bowel disease ( ibd ) patients within a defined uptake area in norway. it is a descriptive study and no hypothesis is predefined. cytokine studies, qol and fatigue assessment will be included for hypothesis-generating purposes.

none considered needed

Eligibility criteria:
inclusion criteria: * newly diagnosed ibd exclusion criteria: * previous ibd with specific treatment within 10 year * inability to consent * inability to adhere to treatment protocol
behavioral exercise intervention for smoking cessation

Conditions: Nicotine Dependence

Summary: the purpose of this study is to test the effect of a moderate-intensity aerobic exercise intervention for smokers interested in quitting smoking. we expect that this project will contribute much needed knowledge about the role of aerobic exercise in smoking cessation. if the efficacy of moderate-intensity, aerobic exercise for smoking can be established, smokers may have a valuable adjunct to more traditional smoking cessation approaches.


Eligibility criteria:
inclusion criteria: 1. are between 18 and 65 years of age 2. are current smokers (i.e., smoking at least 10 cigarettes per day) 3. are sedentary, i.e., have not participated regularly in aerobic physical exercise (for at least 20 minutes per day, 3 days per week) for the past six months. exclusion criteria: 1. current dsm-iv axis i psychiatric disorder as assessed by scid-np 2. substance abuse or dependence (excluding nicotine dependence) within the past 6 months 3. lifetime dsm-iv diagnosis of a bipolar disorder as assessed by the scid-np 4. lifetime history of a psychotic disorder or current psychotic symptoms as assessed by the scid-np 5. current suicidality or homicidality 6. marked organic impairment 7. physical disabilities or medical problems (such as a history of diabetes, hypertension, seizure disorder, coronary heart disease, valvular heart disease, and pulmonary disease) or use of medications (such as beta blockers) that would prevent or hinder participation in a program of moderate intensity exercise 8. current pregnancy of intent to become pregnant during the next 12 weeks, and i) current use of any pharmacotherapy, including transdermal nicotine replacement, for smoking cessation

Keywords: smoking cessation exercise physical activity health education
the effect of music on anxiety in the appointment period

Conditions: Anxiety

Summary: the goal of this randomized clinical trial is to learn if musical intervention can reduce anxiety on patients and doctors in the appointment period. the main questions it aims to answer are: can music reduce the psychological symptoms of anxiety at the end of the appointment? can music reduce heart rate and blood pressure at the end of the appointment? researchers will compare if the presence of zen music during the appointment influences anxiety levels. participants in the intervention group will listen to music during the appointment. those in the control group will not have music in the office during the appointment.


Eligibility criteria:
inclusion criteria: * scheduled appointment; * agree to participate in the clinical trial. exclusion criteria: * 17 years or younger; * deaf; * illiterate.

Keywords: music anxiety heart rate blood pressure appointment
multicenter, national, observational, prospective, real-life study evaluating the performance of 2% aqueous eosin in children with diaper rash

Conditions: Diaper Rash

Summary: this study is being conducted to provide updated clinical data on safety and performance (demonstrated previously for ce marking under the medical devices directive) cooper aqueous eosin 2%. this is an observational study conducted under real-life conditions and as part of post-marketing surveillance activity for a device that has been on the market for a long time and a well-established technology, in accordance with the medical devices regulations 2017 /745 (mdr) and mdcg 2020-6 guidelines. the study will be a multicenter, national, observational, prospective study, with a 7-day follow-up (+/- 2 day). 60 patients are scheduled.


Eligibility criteria:
inclusion criteria: * children under 24 months * with diaper rash for which a prescription for 2% aqueous eosin in a 50 ml vial is made * ssdds score \>= 3/6 * not requiring hospitalization * written consent of one of the parents * affiliated with social security * acceptance of one of the parents to participate in a visit on day 7 in the office or, in case of impossibility, with video/internet consultation or with consultation by phone and sending a photo in this case by the parent(s). exclusion criteria: * antibiotic therapy in progress or prescribed on day 0, or other local therapeutic topicals prescribed on day 0 * children with wounds or likely to be allergic to 2% aqueous eosin or to one of the components of 2% aqueous eosin. * ongoing diarrhoea (change in the consistency of stools (loose or watery) and / or an increase in the number (≥ 3 stools / day).
cognitive rehab for parkinson's

Conditions: Parkinson's Disease; Mild Cognitive Impairment

Summary: this study will examine the feasibility of an at-home cognitive training program that incorporates both memory training and online computerized cognitive training (cct) software. data will also be collected to determine if this program improves thinking and memory as well as everyday function. the hypothesis is that memory and cognitive training combined , compared to memory training alone or will lead to greater improvements in cognitive performance and daily function.

the objective of this study is to examine feasibility of an at-home cognitive rehabilitation program that incorporates both prospective implementation intentions strategies (priis) and an existing web-based executive function (ef) computerized cognitive training (cct) software for veterans with parkinson's disease (pd) and to collect pilot data to determine the impact of this program on cognition and everyday function. the central hypothesis is that cct+priis, compared to cct alone and an active control group, will lead to greater improvements in cognitive performance and daily function. this innovative study uses a set of on-line training games that target aspects of ef susceptible in pd and trains the transfer of cognitive benefits to everyday function, using priis, for veterans with pd and mild cognitive impairment in executive function. additionally, training is conducted at home allowing for convenience and flexibility for participants.

Eligibility criteria:
inclusion criteria: * veterans who seek services at hines va hospital * diagnosis of pd as determined by the uk parkinson's disease society brain bank diagnostic criteria * meet criteria for having mild cognitive impairment * receiving stable (i.e., no changes in medication and medication dose) medication and who are expected to remain on stable medication for the duration of the rct * 50 years or older * speak and read english exclusion criteria: * dementia * failure to demonstrate decision making capacity * cholinesterase inhibitor medication * history of deep brain stimulation surgery * severe depression * severe anxiety * severe apathy

Keywords: parkinson's disease cognition cognitive training prospective memory executive function
systematically assessing effects of colored light on humans with a multi-modal approach (substudy 6 of 7)

Conditions: Exposure to Man-made Visible Light

Summary: note: this is the sixth of in total 7 sub-studies related to the ethics committee of the canton of bern ref. no. kek-be 2016-00674. this sub-study includes 50 participants and 8 arms, in total 350 participants will be assessed in all 7 sub-studies. general study information: this is a randomized, cross-over, quantitative study, which investigates physiological variables, mood, and affect of healthy participants in response to colored light exposure. the participants take part in 5-8 arms and are exposed to colored light only, or are additionally asked to solve cognitive tasks during the colored light exposure. primary aim is to measure the change in several physiological variables, mood, and affect during colored light exposure of 15 or 45 minutes. the risk for the participants is negligible and comparable to the risk during daily life.


Eligibility criteria:
inclusion criteria: * normal color vision * right handed * written informed consent exclusion criteria: * smoking * any kind of diagnosed sleep disorder or neurological or psychiatric disorder in the last 3 months * acute severe traumas * chronic diseases with the necessity for medication * use of recreational drugs * regular intake of medication that would affect the outcome measures * regular excessive alcohol use (\> 18 standard units / week) * transmeridian travel in the last month (crossed \> 1 time zone border) * night shift word during the last month

Keywords: cerebral oxygen metabolism functional near-infrared spectroscopy partial pressure of carbon dioxide heart rate variability blood pressure affect mood respiration systematic randomized cross-over study systemic physiology electro-dermal activity pulse-respiratory quotient
anatomo-radiological study of the ankle's lateral ligament

Conditions: Ankle Injuries and Disorders

Summary: subtalar instability is found in 30% of cases following a severe ankle sprain. treatment is conditioned by subtalar involvement, so detection is essential. there is no consensus on the ligament anatomy of the subtalar region, making precise diagnosis of subtalar ligament damage difficult. the aim of this study is to provide a detailed description of the anatomy of the subtalar ligaments of interest, followed by a detailed radiological description (mri).


Eligibility criteria:
inclusion criteria: * adult patients with no history of sprain on studied ankle exclusion criteria: * sprain on studied ankle

Keywords: ankle subtalar instability mri anatomy
tofacitinib versus cyclosporine for steroid refractory acute severe ulcerative colitis

Conditions: Ulcerative Colitis

Summary: this randomised trial plans to compare oral tofacitinib with intravenous cyclosporine in patients with acute severe ulcerative colitis who have failed to respond to intravenous steroids


Eligibility criteria:
inclusion criteria: patients admitted with acute severe ulcerative colitis as defined by modified truelove and witts criteria with failure to respond to intravenous steroids (hydrocortisone 100 mg iv qid or iv methylprednisolone 60 mg iv od) as defined by * day 3 non-response as per oxford criteria (stool frequency of \> 8/day, or stool frequency between 3-8 with crp \> 45 mg/l plus * ongoing activity as defined by partial mayo score of \> 3 (rectal bleeding sub-score of \>1) * decision to start second line therapy (within 5-7 days of starting intravenous steroids) exclusion criteria: * age \ 65 years * e1 disease (involvement distal to rectosigmoid junction only) * crohn's disease * contraindication to intravenous cyclosporine or oral tofacitinib * renal failure, uncontrolled hypertension, seizure disorder,and uncorrected hypomagnesemia (\<1.5 mg/l) * previous thrombosis, or prothrombotic state, on oral contraceptive, history of herpes zoster, active tb, active hepatitis, past opportunistic infections, h/o diverticulitis, age \>50 plus at least one cardiac risk factor * patient wants treatment with intravenous infliximab or wants surgery * underlying sepsis or active infection (enteric infections, clostridium difficile, active hepatitis b or c, tuberculosis, zoster, cmv disease) * toxic megacolon, previous dysplasia or any indication of immediate surgery * known malignancy * pregnancy or lactation * unwilling to provide consent or for follow-up