Kornimate/medical-research-clean huggingface dataset:
mrd monitoring by digital droplet pcr in the early period after allo-hsct to predict patients at high risk of relapse

Conditions: Measurable Residual Disease

Summary: a study on the effectiveness of digital droplet pcr in monitoring measurable residual disease during the early period after allogeneic hematopoietic stem cell transplantation to predict patients at high risk of relapse

this is a retrospective and multicenter clinical study.this study is indicated for patients with hematological malignancies who underwent allo-hsct. it aims to evaluate the effectiveness of digital droplet pcr in monitoring measurable residual disease during the early period after allogeneic hematopoietic stem cell transplantation to predict patients at high risk of relapse. 192 patients will be enrolled. the clinical end points include cumulative incidence of relapse, relapse-free survival, non-relapse mortality, and overall survival.

Eligibility criteria:
inclusion criteria: 1. the presence of at least one haematological tumour-associated mutation or fusion gene detected at diagnosis by ngs or real-time qpcr provided for posttransplant mrd monitoring; 2. successful stem cell engraftment 3. received at least one bone marrow mrd detection by ddpcr in +30 days to +120 days after hsct; 4. age 12-70 exclusion criteria: 1. patients who relapsed or died before the first ddpcr monitoring; 2. patients with only germline mutations.

Keywords: droplet digital pcr allogeneic hematopoietic stem cell transplantation relapse
effectiveness study of integrative treatment for pediatric community acquired pneumonia

Conditions: Pneumonia

Summary: the purpose of this study is to evaluate the effectiveness of traditional chinese medicine for treatment of pediatric pneumonia. it is a multicenter randomized controlled trial.

the block randomization is used in this trial. random numbers are generated by statistical analysis system(sas) software. statistical analysis staff and those who perform the follow-up are blinded. sample size calculation was performed, which was 1164 , and considering drop-out or withdrawal, investigators plan to enroll 1500 patients (500 in experimental group 1, 500 in experimental group 2, 500 in experimental group 3).

Eligibility criteria:
inclusion criteria: * children,aged 1 to 14 years old; * diagnosed as pneumonia according to western medicine diagnostic criteria; * diagnosed as tcm pneumonia with pneumonia with dyspnea and cough, meeting wind-heat blocking lungs pattern (feng re bi fei zheng), and phlegm-heat blocking lungs pattern(tan re bi fei zheng); * disease progression within 72 hours; those whose guardians understood and assigned the informed consent; exclusion criteria: * severe pneumonia; * complicated with other pulmonary disorders attack other than pneumonia; * complicated with primary disease of heart(congenital heart disease, myocarditis, et al),liver(alanine aminotransferase(alt),and aspartate transaminase(ast) ≥1.5 times of normal value ceiling),kidney (blood urea nitrogen(bun) \>8.2mmol/l, or serum c reactive protein \>104umol/l,et al) and blood system (anemia) ,and those with psychopathy; * allergic to interventional medications; those who are participating or have participated in other clinical trials in 3 months; * those who intend to lost follow-up by practitioners' judgment.

Keywords: pneumonia pediatrics
safety and performance evaluation of the nephronyx system for the treatment of patients with adhf

Conditions: Acute Decompensated Heart Failure

Summary: the objective of this interventional study is to evaluate the safety and functional performance of the nephronyx system in patients with adhf, presenting clinical signs of volume overload and compromised response to diuretics.


Eligibility criteria:
inclusion criteria: * patient admitted to the hospital with a primary diagnosis of adhf * patient has signs of volume overload as evidence by a score of ≥ 4 on the everest score * patient with left ventricular ejection fraction lvef \>15% * patient has compromised response to diuretics * nt-probnp \>450 pg/ml if aged \ 900 pg/ml if aged between 55 and 75 years and \>1800 pg/ml if aged \>75 years exclusion criteria: * patient with active dvt or history of dvt * patient has documented or evidence of renal artery stenosis * bmi\>35 kg/m\^2 * patient has documented, untreated symptomatic coronary artery disease (cad) requiring revascularization * patient is in cardiogenic shock * patient has blood dyscrasia, acute anemia, thrombocytopenia, bleeding diathesis, or coagulopathy * temperature \> 38°c, or sepsis, or active systemic infection requiring iv anti-microbial treatment * patient has shown liver cirrhosis or has signs of liver damage
motivational interview based discharge planning for patients with diabetic foot ulcers

Conditions: Diabetic Foot Ulcer

Summary: to evaluate the effectiveness of a discharge planning using the strategy of motivational interviewing among patients with diabetic foot ulcers

the purpose of this study is to evaluate the effectiveness of a discharge planning using the strategy of motivational interviewing among patients with diabetic foot ulcers. a randomized controlled trial design will be used. from august 2020 to july 2022, 132 patients hospitalized for diabetic foot ulcers will be recruited. they will be randomly assigned to either the experimental or the comparison group in the first year, and then they will be followed by one year. the control group will receive routine care; the experimental group will receive a discharge planning which use the strategy of motivational interviewing. the discharge planning will be provided individually at the following time points: before discharge, on post-discharge days 3, 7, 14, 21, 28, and then each month till one year. outcome measures include diabetic foot ulcer self-care behaviors and self-efficacy, foot skin conditions, glycemic control (measured by hba1c), the infection rate of foot, and the readmission rate. data will be collected at baseline and at 1, 3, 6, and 12 months after discharge. the generalized estimating equation (gee) will be used to evaluate the effect of the intervention on the diabetic foot ulcer self-care behaviors and self-efficacy, foot skin conditions, and the effect on glycated hemoglobin value reduction. the log-rank test will be used to compare the infection rate of foot, and the readmission rate between two groups.

Eligibility criteria:
inclusion criteria dfu inpatient could communicate with mandarin or taiwanese hba1c value higher or equal to 7.5 % wagner stage 1 or 2 foot ulcer. exclusion criteria cognitive impairment communication problems affected foot has been amputated autoimmune disease be unable to perform daily self-care activity be cared by foreigner and no other family members live together plan to move to a long-term care facility unwilling to visit the outpatient clinic at the research setting c-reactive protein values are higher than 15 mg/dl

Keywords: foot ulcer, motivational interviewing, discharge planning
evaluation of the feasibility a new silicone hydrogel contact lens

Conditions: Myopia

Summary: the objective of this study is to determine the clinical feasibility and to evaluate the product performance of an investigational contact lens.


Eligibility criteria:
inclusion criteria: * have physiologically normal anterior segments not exhibiting clinically significant biomicroscopy findings. * be myopic and require lens correction in each eye. * be adapted wearers of soft contact lenses, wear a lens in each eye, and each lens must be of the same manufacture and brand. exclusion criteria: * any systemic disease affecting ocular health. * using any systemic or topical medications that will affect ocular physiology or lens performance. * an active ocular disease, any corneal infiltrative response or are using any ocular medications. * any "present" finding during the slit lamp examination that, in the investigator's judgment, interferes with contact lens wear. * allergic to any component in the study care products.
oral qlt091001 in retinitis pigmentosa (rp) subjects with an autosomal dominant mutation in retinal pigment epithelial 65 protein (rpe65)

Conditions: Retinitis Pigmentosa (RP)

Summary: the purpose of this study is: * to evaluate whether 7-day treatment with oral qlt091001 can improve visual function in rp subjects with an autosomal dominant mutation in rpe65. * to evaluate duration of visual function improvement (if observed) in rp subjects with an autosomal dominant mutation in rpe65 after 7-day treatment with oral qlt091001. * to evaluate the safety of oral qlt091001 administered once daily for 7 days in rp subjects with an autosomal dominant mutation in rpe65.


Eligibility criteria:
inclusion criteria: * subjects will have rp caused by an autosomal dominant mutation in rpe65, as diagnosed by an ocular geneticist or ophthalmologist. * subjects who have a best-corrected standard etdrs visual acuity of 3 letters or better (20/800 snellen equivalent) or visible photoreceptor outer segments on oct/faf. exclusion criteria: * subjects with any clinically important abnormal physical finding at screening. * subjects who have taken any prescription or investigational oral retinoid medication (e.g., accutane/roaccutane® or soriatane/neotigason®) within 6 months of day 0 and subjects who did not tolerate their previous oral retinoid medication will be excluded regardless of the time of last exposure. * subjects with a history of diabetes or chronic hyperlipidemia, hepatitis, pancreatitis, or cirrhosis. * subjects who have taken any supplements containing ≥10,000 iu vitamin a within 60 days of screening.
elastic band exercise on the pain, kinesiophobia, functional, and psychological status

Conditions: Exercise

Summary: aiming to determine the effects of elastic band exercise on kinesiophobia, functional capacity, and depression after the total knee arthroplasty, the present study was designed and carried out as a randomized controlled trial study. the study was carried out between october 2019 and april 2020 in the physical therapy and rehabilitation department of a training and research hospital.this study, the effects of elastic band exercise program on the pain, kinesiophobia, quality of life, depression, and functional capacity of tka patients were examined. elastic band exercise program significantly decreased the pain level, exercise fear, and depression level of patients and positively contributed to the quality of life and functional capacity.

all the participants were subjected to walking training and a standard postoperative care and exercise protocol until discharged from the hospital. during discharging, all the participants in both groups were provided with explanation and illustration about how to perform the exercises. in order to prevent any problem, the participants in both groups were recommended to start the at-home rehabilitation programs, which incorporate knee movement exercises, to be ready 2 weeks (14 days) after the surgery and they were asked to continue their current exercise programs thus far. the patients in control group were recommended to maintain only an at-home exercise program incorporating knee flexion and extension exercises. the patients in intervention group were recommended to do, in addition to the at-home exercise program given to the patients in control group, elastic band exercises and researchers showed them how to use the elastic bands by making use of instructions.the participants were asked to do exercise 4 times a day with a minimum of 2 hours interval between the sessions. the participants were instructed to avoid elastic band exercise 1 hour before or after the meals in order to prevent a physical impairment and to adopt a moderately progressive approach in order to prevent lower extremity pain after exercise and to increase the sense of success and confidence.

Eligibility criteria:
inclusion criteria: unilateral total knee arthroplasty exclusion criteria: bilateral total knee arthroplasty

Keywords: elastic band exercise kinesiophobia functional, psychological status
education programme on continuous positive airway pressure treatment

Conditions: Obstructive Sleep Apnea

Summary: the purpose of this study is to examine whether an education programme would enhance continuous positive airway pressure (cpap) adherence.

obstructive sleep apnoea (osa) is a common sleep disorders associated with excessive daytime sleepiness and cardiovascular disease. it is prevalent both in populations of western and eastern countries. continuous positive airway pressure (cpap) therapy is an effective standard treatment and is widely prescribed for patients with osa. however, the use of cpap for such patients is disappointingly low. low patient cpap adherence limits the effectiveness of treatment. to determine whether there is a need for an extended education programme for the osa patient in order to improve cpap usage.

Eligibility criteria:
inclusion criteria: 1. aged 18 years or over. 2. newly diagnosed of osa and will be starting cpap therapy exclusion criteria: 1. not suitable for cpap therapy 2. previously received cpap therapy 3. possesses restrictive and obstructive pulmonary diseases 4. possesses hypoventilation 5. under unstable health conditions 6. pregnant 7. history of psychiatric illness

Keywords: continuous positive airway pressure treatment adherence education
post market clinical follow-up touch® cmc 1

Conditions: Osteoarthritis Thumb

Summary: because severe pain, weakened pinch and grip strength produce functional disabilities, the basal joint of the thumb is the most common site of surgical reconstruction in the upper limb due to oa. the cement-free dual mobility touch® prosthesis consists of a metacarpal implant (stem), a trapezium implant (cup), and a connection implant (neck). the main objective of this study is to describe the performance and safety of the touch® prosthesis used with its instruments set in accordance with its intention and ce marking in force. performance and safety will be assessed over the short and long term in accordance with the life cycle of the touch® prosthesis.


Eligibility criteria:
inclusion criteria: * adult patients (age ≥ 18 years), * patients suffering from rhizarthrosis (i - iv based on the dell classification), * pain \>3 on the vas scale, * patients to undergo a replacement of the trapeziometacarpal joint with the touch® dual mobility trapeziometacarpal prosthesis. exclusion criteria: * pregnant women, * patients with contraindications to surgery in general, * patients suffering from temporary regional pain syndrome (trps), * patients with a severe or chronic, local or systemic infection, * patients with severe muscle, neurological or vascular impairments affecting the trapezium-metacarpal joint, * patients with bone demineralization or destruction that may affect the proper fixation of the implant, * patients whose bone dimensions are incompatible with the implant dimensions, * the combination of the touch® prosthesis with other components of another origin is not authorized, * patients with allergies to the components of the product or with known allergies (chromium, cobalt, nickel), * patients with an intellectual disability who cannot, therefore, follow the instructions of their surgeon, * patient with scaphoid-trapezium-trapezoid (stt) arthritis, * patient requiring revision of a trapeziometacarpal prosthesis, * patient who has undergone a tmc joint infiltration within 3 months of the expected date of replacement of the joint with a touch® prosthesis.
the syn-sleep study

Conditions: REM Sleep Behavior Disorder (iRBD)

Summary: in collaboration with approximately 8 centers that specialize in irbd we will recruit a total of 80 individuals for the study. all subjects will be enrolled into a 2-year longitudinal study where skin biopsies will be performed at 3 sites on each patient at 12-month intervals (baseline, year 1, year 2). plasma blood collection will be performed at 12-month intervals (baseline, year 1, year 2). detailed quantified examination, cognitive evaluation, medical history, and questionnaires will be performed at each visit. additional biomarker, imaging and clinical information (if available) will be obtained for the purpose of determining phenoconversion to clinically apparent synucleinopathy. subjects enrolled in the study will have baseline evaluations and follow up visits at 12 and 24 months to define any changes to clinical diagnosis (clinical phenoconversion). skin biopsies will be repeated at the 12- and 24-month follow up visits to determine the rate of p-syn accumulation over time and the rates of nerve fiber degeneration within punch skin biopsies.


Eligibility criteria:
inclusion criteria: 1. males and females age 18-85 2. subjects will have repeated episodes of sleep related vocalizations and/or complex motor behaviors 3. sleep-related behaviors/disturbances must be documented by polysomnography to occur during rem sleep 4. polysomnographic recording is consistent with rem sleep without atonia exclusion criteria: 1. subjects with moca \ /=1, contraindications to skin biopsy 2. diagnosis of parkinson's disease 3. diagnosis of dementia of any type 4. diagnosis of multiple system atrophy 5. rem sleep behaviors/disturbances secondary to another cause (e.g., narcolepsy, dementia, and parkinson's disease) 6. contra-indications to skin biopsy: 1. clinical evidence of severe vascular disease (history of ulceration, poor wound healing, and vascular claudication) 2. history of allergic reaction to local anesthesia for skin biopsies 3. use of blood thinners (aspirin of plavix alone is allowed) 4. significantly impaired wound healing or history of scarring or keloid formation
a prospective, randomized, open, parallel-controlled, superior-efficacy clinical study of radical sigmoidectomy for sigmoid cancer versus radical sigmoidectomy combined with indocyanine green fluorescence imaging lymphatic tracing dissection in the treatment of sigmoid cancer

Conditions: Sigmoid Cancer

Summary: he purpose of this study is to explore the clinical outcomes of indocyanine green tracer using in laparoscopic radical sigmoidectomy for sigmoid adenocarcinoma (ct2-t4a n0 m0，t1-t4a n+ m0).


Eligibility criteria:
inclusion criteria: 1. age between 18 and 75 years old 2. confirmed sigmoid adenocarcinoma cancer pathologically 3. location of tumor: the sigmoid colon (descending colon from vertical to horizontal point) is the starting point of sigmoid colon, and the end point of sigmoid colon is at 15cm of anal margin. 4. ct showed sigmoid colon cancer: t3-4a n+ m0 5. patients with non-local recurrence or distant metastasis; 6. no multiple colorectal cancer; 7. no neoadjuvant therapy; 8. physical conditions such as heart, lung, liver and kidney function can tolerate surgery. 9. willing and able to provide written informed consent for participation in this study exclusion criteria: 1. complicated with other malignant tumors or previous history of malignant tumors; 2. patients with intestinal obstruction, intestinal perforation, intestinal bleeding, etc.; 3. patients with tumor invasion or involvement of adjacent organs requiring combined organ resection; 4. patients with poor anal function and incontinence before operation; 5. patients with inflammatory bowel disease or familial adenomatous polyposis 6. asa grade ≥ iv and / or ecog physical status score \> 2; 7. patients with severe hepatorenal function, cardiopulmonary function, blood coagulation dysfunction or severe underlying diseases unable to tolerate surgery; 8. history of severe mental illness; 9. pregnant or lactating women; 10. patients with uncontrolled infection before operation; 11. patients with other clinical and laboratory conditions considered by some researchers should not participate in this trial.
phase 2 study to assess the safety, pk, and pd in sbs-if subjects

Conditions: Short Bowel Syndrome

Summary: this is a randomized, double-blind, placebo-controlled, proof-of-concept (poc), phase 2 study to assess the safety, pk, and pd of sc administration of hm15912(sonefpeglutide) in adult subjects with sbs-associated intestinal failure (sbs-if).

the study consists of a screening period, a run-in period, a 6-months core treatment period, a 7-months extension treatment period and a 1-month safety follow-up period.

Eligibility criteria:
inclusion criteria: 1. men or women, aged 18 years of age or older with sbs resulting in intestinal failure at the time of signing the informed consent form (icf) (or country's legal age of majority if the legal age is \<18 years) 2. capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the icf and in this protocol 3. diagnosis of sbs with the latest intestinal resection being at least 6 months prior to screening and considered stable regarding the pn/iv need. no restorative surgery planned in the study period. exclusion criteria: 1. any history of colon cancer. 2. history of any other cancers (except margin-free resected cutaneous basal or squamous cell carcinoma or adequately treated in situ cervical cancer) unless disease-free for at least 5 years 3. history of alcohol or drug abuse (within 1 year of screening)
efficacy of hippotherapy simulator exercise program in stroke patients

Conditions: Stroke

Summary: the aim of our study is to investigate the effects of hippotherapy simulator exercises in addition to the conventional rehabilitation program on the balance, postural control, mobility, functional capacity, and independence levels of stroke patients.

twenty-six 18- 65 years of patients with stroke were included in the study. patients were divided into two groups as hippotherapy simulator group (hsg) (n = 13) and conventional exercise group (ceg) (n = 13). patients were evaluated with berg balance scale (bbs) for balance, postural assessment scale for stroke (pass) for postural control, rivermead mobility index (rmi), and time up- go test (tug) for mobility, 2min. walking test (2mwt) for functional capacity and barthel index (bi) for the level of independence respectively before and after treatment.

Eligibility criteria:
inclusion criteria: * getting a diagnosis of stroke by a specialist physician, * being between the ages of 18-65, * having a stroke history of 3- 36 months, * to be able to sit without support while both soles are in contact with the floor, * to be able to walk independently with or without using a walking aid, * to be able to understand and follow audio and visual warnings, * scoring 24 points or more from the mini-mental state exam. exclusion criteria: * multiple stroke stories, * hemorrhagic type stroke history, * those with a history of falling in the past 1 year, * those with a history of epilepsy, * uncontrolled history of hypertension and diabetes

Keywords: hippotherapy cerebrovasculer disorders stroke rehabilitation balance exercise